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CompletedNCT01144377Updated Sep 17, 2019Results posted

A Study of LY2541546 in Women With Low Bone Mineral Density

A Phase 2 interventional study of LY2541546 and Placebo in Osteoporosis, sponsored by Eli Lilly and Company. Completed at 8 sites in 5 countries. Open to female participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-09-17.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
Female
01

Study summary

The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).

02

Conditions studied

  • Osteoporosis

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Keywords

  • osteoporosis
03

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's enrollment of 154 is above the median of 95 across 1,152 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ambulatory, postmenopausal women, inclusive.
  • Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute value (grams/square centimeter [g/cm\^2]) for the lumbar spine of between -3.5 and -2.0, inclusive.
  • Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures.
  • Willing to take study drug and daily supplements (calcium and Vitamin D).
  • Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits, and platelet level greater than 100,000 cubic millimeters (mm\^3).

Exclusion criteria

Exclusion Criteria:

  • Have received treatment with any of the following medications more recently than 3 months prior to screening Androgen, Calcitonin, Estrogen (including over the counter preparations known to have estrogenic activity), Progestin (including over the counter preparations known to have progestogenic activity), selective estrogen receptor modulators (SERMs) (Raloxifene, Tamoxifen, Toremifene, Clomiphene), or Tibolone.
  • Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
  • Have received treatment with any oral bisphosphonate within the last year.
  • Have received therapeutic doses of systemic corticosteroids for more than one month during the 6 months prior to screening.
  • Have received therapeutic doses of fluorides (20 milligrams per day) for more than 3 months during the last 3 years, or for more than a total of 2 years, or any within the last 6 months.
  • Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than \<9.2 nanograms per milliliter (ng/mL) [23 nanomoles per liter (nmol/L)] at screening. If the serum 25-hydroxy-vitamin D level at screening is less than or equal to 9.2 ng/mL and \<20 ng/mL, participants will receive a loading dose of Vitamin D (at a dose of approximately 100,000 international units (IU) given orally) prior to enrollment.
  • Have any known bone disorder other than low BMD or osteoporosis.
  • Have a history of osteoporotic fractures, including known prevalent vertebral fracture or evidence of prevalent vertebral fracture on screening spine X-ray or dual-energy x-ray absorptiometry (DXA), or are considered to be at high risk for fracture.
  • Presence of any abnormality (such as artifacts or osteophytes) that would confound DXA evaluation of lumbar vertebrae in the L-1 through L-4 region.
  • Have a history of Bell's palsy, other cranial nerve disorders, or have a history of Temporomandibular Joint and Muscle Disorders (TMJDs).
  • Have any history of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
  • Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of constituting a risk when taking the study medication or of interfering with the interpretation of data.
  • Have acute or chronic liver disease ([bilirubin >34 micromoles per liter (µmol/L) or >2.0 milligrams per deciliter (mg/dL), alanine transaminase [ALT/SGPT] >100 units per liter (U/L), or alkaline phosphatase >300 U/L)].
  • Have impaired kidney function serum creatinine >135 µmol/L or >2.0 mg/dL.
  • Have known allergy to LY2541546, any of diluents or excipients of LY2541546, or significant allergy to any other monoclonal antibody.
  • History of excessive consumption of alcohol or abuse of drugs within the last year.
  • Have poor medical condition or psychiatric risks for treatment with an investigational drug.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    180 mg LY2541546 Q4W + Placebo

    LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.

    Drug: LY2541546 · Drug: Placebo

  • Experimental
    180 mg LY2541546 Q2W

    LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks.

    Drug: LY2541546

  • Experimental
    270 mg LY2541546 Q2W

    LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks.

    Drug: LY2541546

  • Experimental
    270 mg LY2541546 Q12W + Placebo

    LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.

    Drug: LY2541546 · Drug: Placebo

  • Placebo comparator
    Placebo Comparator Q2W

    Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.

    Drug: Placebo

Interventions

  • DrugLY2541546

    Administered subcutaneously

    Also known as: Blosozumab

  • DrugPlacebo

    Administered subcutaneously

06

What researchers measure

Primary outcomes

  1. Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)

    Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.

    Time frame: Baseline, 52 weeks

Secondary outcomes

  1. Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)

    Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate

    Time frame: Baseline, 12 weeks and 24 weeks and 64 weeks

  2. Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)

    Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.

    Time frame: Baseline, 24 weeks and 52 weeks and 64 weeks

  3. Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)

    Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.

    Time frame: Baseline, 52 weeks

  4. Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)

    Time frame: Baseline, 52 weeks

  5. Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)

    Time frame: Baseline, 52 weeks

  6. Change From Baseline to 52 Week Endpoint in Osteocalcin

    Time frame: Baseline, 52 weeks

  7. Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)

    Time frame: Baseline, 52 weeks

07

Results

Posted Dec 4, 2017

Participant flow

52 Week Treatment Period
Participant flow — 52 Week Treatment Period
Milestone180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Started3130302637
Received at least one dose of study drug3130302537
Completed2629252234
Not completed51543
Withdrew: Adverse event00321
Withdrew: Entry criteria not met00110
Withdrew: Protocol violation00001
Withdrew: Lost to follow-up10000
Withdrew: Withdrawal by subject41110
Withdrew: Sponsor decision00001
12 Week Safety Follow-up Period
Participant flow — 12 Week Safety Follow-up Period
Milestone180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Started2629252234
Completed2629252234
Not completed00000
Optional 40 Week Safety Follow-up Period
Participant flow — Optional 40 Week Safety Follow-up Period
Milestone180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Started222523323
Completed212423321
Not completed11002
Withdrew: Adverse event01001
Withdrew: Lost to follow-up00001
Withdrew: Sponsor decision10000

Outcome measures

PrimaryChange From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)

Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.

Time frame:
Baseline, 52 weeks
Reported as:
Least squares mean · g/cm^2
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)
g/cm^2180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)0.065 (0.048 to 0.082)0.115 (0.099 to 0.131)0.142 (0.125 to 0.158)0.054 (0.036 to 0.073)-0.011 (-0.026 to 0.004)
SecondaryChange From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)

Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate

Time frame:
Baseline, 12 weeks and 24 weeks and 64 weeks
Reported as:
Least squares mean · g/cm^2
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
g/cm^2180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Week 120.028 (0.020 to 0.037)0.048 (0.039 to 0.057)0.057 (0.048 to 0.065)0.039 (0.029 to 0.049)-0.007 (-0.015 to 0.001)
Week 240.049 (0.037 to 0.061)0.083 (0.071 to 0.094)0.098 (0.086 to 0.109)0.048 (0.035 to 0.061)-0.006 (-0.016 to 0.004)
Week 640.046 (0.032 to 0.061)0.098 (0.083 to 0.112)0.135 (0.120 to 0.150)0.046 (0.029 to 0.062)-0.007 (-0.020 to 0.006)
SecondaryChange From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)

Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.

Time frame:
Baseline, 24 weeks and 52 weeks and 64 weeks
Reported as:
Least squares mean · g/cm^2
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
g/cm^2180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Femoral Neck BMD Week 240.010 (0.002 to 0.019)0.017 (0.009 to 0.025)0.026 (0.018 to 0.034)0.002 (-0.007 to 0.011)0.002 (-0.005 to 0.009)
Total Hip BMD Week 240.007 (-0.001 to 0.014)0.020 (0.013 to 0.027)0.031 (0.024 to 0.039)0.015 (0.007 to 0.023)-0.007 (-0.014 to -0.001)
Femoral Neck BMD Week 520.018 (0.010 to 0.026)0.025 (0.017 to 0.033)0.044 (0.035 to 0.052)0.014 (0.005 to 0.024)0.003 (-0.005 to 0.010)
Total Hip BMD Week 520.017 (0.008 to 0.025)0.032 (0.023 to 0.040)0.051 (0.043 to 0.060)0.019 (0.009 to 0.029)-0.004 (-0.012 to 0.003)
Femoral Neck BMD Week 640.016 (0.007 to 0.026)0.028 (0.019 to 0.037)0.038 (0.029 to 0.048)0.013 (0.002 to 0.023)0.002 (-0.007 to 0.010)
Total Hip BMD Week 640.011 (0.001 to 0.020)0.031 (0.022 to 0.040)0.047 (0.038 to 0.056)0.021 (0.011 to 0.030)-0.007 (-0.015 to 0.001)
SecondaryChange From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)

Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.

Time frame:
Baseline, 52 weeks
Reported as:
Least squares mean · g/cm^2
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)
g/cm^2180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)-0.005 (-0.011 to 0.001)-0.005 (-0.010 to 0.001)-0.001 (-0.007 to 0.005)-0.002 (-0.009 to 0.004)-0.005 (-0.010 to 0.000)
SecondaryChange From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)
Time frame:
Baseline, 52 weeks
Reported as:
Median · units/liter
Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)
units/liter180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)-6.000 (-12.600 to 0.300)-2.000 (-10.400 to 4.500)1.600 (-4.400 to 9.800)-3.150 (-10.000 to 2.900)-3.900 (-11.400 to 4.300)
SecondaryChange From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)
Time frame:
Baseline, 52 weeks
Reported as:
Median · nanograms/milliliter
Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)
nanograms/milliliter180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)-0.014 (-0.116 to 0.079)-0.088 (-0.191 to 0.030)-0.038 (-0.199 to -0.009)-0.022 (-0.076 to 0.029)0.037 (-0.076 to 0.129)
SecondaryChange From Baseline to 52 Week Endpoint in Osteocalcin
Time frame:
Baseline, 52 weeks
Reported as:
Median · micrograms/liter
Change From Baseline to 52 Week Endpoint in Osteocalcin
micrograms/liter180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Change From Baseline to 52 Week Endpoint in Osteocalcin-2.087 (-3.998 to 2.411)-0.764 (-7.762 to 3.704)0.823 (-3.704 to 5.116)-3.322 (-5.586 to 4.822)-2.029 (-6.880 to 2.587)
SecondaryChange From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)
Time frame:
Baseline, 52 weeks
Reported as:
Median · nanograms/milliliter
Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)
nanograms/milliliter180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)-12.250 (-19.300 to 1.300)-4.200 (-27.200 to 6.700)-1.100 (-12.800 to 10.200)-16.050 (-21.700 to 0.100)-5.800 (-11.550 to 5.450)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
180 mg LY2541546 Q4W + Placebo—4/31 (12.9%)30/31 (96.8%)
180 mg LY2541546 Q2W—3/30 (10%)28/30 (93.3%)
270 mg LY2541546 Q2W—4/30 (13.3%)29/30 (96.7%)
270 mg LY2541546 Q12W + Placebo—1/25 (4%)21/25 (84%)
Placebo Q2W—2/37 (5.4%)34/37 (91.9%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
Event180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/311/302/300/250/37
Cerebral infarctionNervous system disorders0/310/300/300/252/37
Uterine prolapseReproductive system and breast disorders0/310/300/301/250/37
Cardiac failureCardiac disorders0/311/300/300/250/37
Retinal artery occlusionEye disorders0/310/301/300/250/37
PneumoniaInfections and infestations0/311/300/300/250/37
Metastases to boneNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/311/300/300/250/37
Metastases to lymph nodesNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/311/300/300/250/37
Spinal cord ischaemiaNervous system disorders0/310/301/300/250/37
Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders0/311/300/300/250/37
Most frequent other events
Showing 10 of 75
Most frequent other events
Event180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2W
NasopharyngitisInfections and infestations16/318/3011/307/2512/37
Injection site bruisingGeneral disorders1/313/302/306/253/37
Injection site swellingGeneral disorders6/313/305/302/250/37
Blood 1,25-dihydroxycholecalciferol increasedInvestigations6/314/304/302/255/37
Back painMusculoskeletal and connective tissue disorders6/313/302/302/254/37
DiarrhoeaGastrointestinal disorders0/315/303/301/252/37
Injection site painGeneral disorders4/315/301/301/251/37
Injection site pruritusGeneral disorders2/315/304/300/250/37
ContusionInjury, poisoning and procedural complications3/311/302/300/255/37
ArthralgiaMusculoskeletal and connective tissue disorders2/313/302/302/255/37

Baseline characteristics

Participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
Mean66.78 ± 8.9864.17 ± 8.2066.12 ± 7.6863.56 ± 8.0265.17 ± 8.9165.22 ± 8.38
Sex: Female, Male
Sex: Female, Male(Participants)180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
Female3130302537153
Male000000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
Hispanic or Latino4429827
Not Hispanic or Latino2324261626115
Unknown or Not Reported4220311
Race (NIH/OMB)
Race (NIH/OMB)(Participants)180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
American Indian or Alaska Native000000
Asian141313111465
Native Hawaiian or Other Pacific Islander000000
Black or African American000011
White171717142287
More than one race000000
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(Participants)180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
United States465111036
Estonia4353419
Lithuania3440415
Denmark6430518
Japan141313111465
Lumbar Spine Bone Mineral Density (Baseline)
Lumbar Spine Bone Mineral Density (Baseline)(grams/square centimeter (g/cm^2))180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
Mean0.78 ± 0.090.78 ± 0.070.80 ± 0.090.77 ± 0.090.78 ± 0.090.78 ± 0.09
Femoral Neck Bone Mineral Density (Baseline)
Femoral Neck Bone Mineral Density (Baseline)(g/cm^2)180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
Mean0.66 ± 0.150.66 ± 0.150.69 ± 0.110.63 ± 0.110.66 ± 0.170.66 ± 0.14
Total Hip Bone Mineral Density (Baseline)
Total Hip Bone Mineral Density (Baseline)(grams/square centimeter)180 mg LY2541546 Q4W + Placebo180 mg LY2541546 Q2W270 mg LY2541546 Q2W270 mg LY2541546 Q12W + PlaceboPlacebo Q2WTotal
Mean0.75 ± 0.110.75 ± 0.130.77 ± 0.100.73 ± 0.110.73 ± 0.140.75 ± 0.12
08

Study locations

8 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Gainesville, Georgia 30501, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Bethesda, Maryland 20817, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Hvidovre, 2650, Denmark
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Vejle, 7100, Denmark
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Tallinn, 10128, Estonia
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Nagano, 386-0493, Japan
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Tokyo, 166-0003, Japan
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Vilnius, 10323, Lithuania
09

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01144377
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 15, 2010
Start date
Aug 2010
Primary completion
May 2012
Completion
Feb 2013
Results posted
Dec 4, 2017
Last update
Sep 17, 2019

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Blosozumab

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