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CompletedNCT00431444Updated Mar 29, 2011Results posted

Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density

A Phase 4 interventional study of Raloxifene and Zoledronic acid in Osteoporosis, sponsored by Novartis. Completed at 17 sites in United States. Open to female participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-03-29.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
Female
01

Study summary

This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.

02

Conditions studied

  • Osteoporosis

Keywords

  • Osteoporosis
  • Post-menopausal
  • Bone mineral density
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 110 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:
  • Cessation of menses for 18 months in women \< 50 years of age
  • Cessation of menses for 12 months in women age 50 years or over
  • Documented bilateral oophorectomy at least 1 year previously
  • Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis
  • Signed informed consent prior to initiation of any study procedure

Exclusion criteria

Exclusion Criteria:

  • Prior treatment with i.v. bisphosphonates within the last 2 years
  • Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*).
  • *NOTE: If used less than 8 weeks, the washout period is 6 months.
  • Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
  • Any treatment with strontium renalate, sodium fluoride or parathyroid hormone
  • Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year
  • Treatment with any investigational drug within 30 days prior to randomization
  • Any woman of child bearing potential
  • Patients with fractures occurring within three months prior to randomization
  • History of hypersensitivity to bisphosphonates
  • History of non-traumatic uveitis or iritis, within 2 years prior to study entry.
  • A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
  • Previous major solid organ transplant recipient or on a transplant waiting list
  • History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
  • Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months
  • Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial
  • Active dental infection, unhealed dental extraction or planned oral surgery within 3 month prior to randomization.
  • Calculated creatinine clearance \< 30 mL/min
  • Greater than 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
  • Serum calcium > 2.75 mmol/L (11.0 mg/dL) or \< 2.08 mmol/L (8.3 mg/dL) at screening
  • AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Active comparator
    Zoledronic Acid

    Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group)

    Drug: Zoledronic acid · Drug: Placebo oral pills

  • Active comparator
    Raloxifene

    Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)

    Drug: Raloxifene · Drug: Placebo intravenous (i.v.) infusion

Interventions

  • DrugRaloxifene
  • DrugZoledronic acid

    Also known as: Reclast, Aclasta

  • DrugPlacebo oral pills
  • DrugPlacebo intravenous (i.v.) infusion
06

What researchers measure

Primary outcomes

  1. Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)

    The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Change From Baseline in Urine NTx at 2 Months

    The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

    Time frame: Baseline and 2 months

  2. Change From Baseline in Urine NTx at 4 Months

    The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

    Time frame: Baseline and 4 months

  3. Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months

    Time frame: Baseline and 2 months

  4. Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months

    Time frame: Baseline and 4 months

  5. Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months

    Time frame: Baseline and 6 months

  6. Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire

    The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

    Time frame: Immediately after infusion procedure

  7. Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire

    The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

    Time frame: Immediately after infusion procedure

  8. Overall Patient Satisfaction Assessed by Satisfaction Questionnaire

    Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

    Time frame: Immediately after infusion procedure

  9. Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens

    At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: "once a year i.v. infusion," "once daily pill," or "both are equal."

    Time frame: At 6 month visit

07

Results

Posted Mar 11, 2011

Participant flow

Participant flow — Overall Study
MilestoneZoledronic AcidRaloxifene
Started5653
Completed5146
Not completed57
Withdrew: Protocol violation14
Withdrew: Adverse event21
Withdrew: Withdrawal by subject11
Withdrew: Lost to follow-up10
Withdrew: Administrative problems01

Outcome measures

PrimaryChange From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)

The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

Time frame:
Baseline and 6 months
Reported as:
Mean · nM BCE/mM Cr
Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
nM BCE/mM CrZoledronic AcidRaloxifene
Baseline (n = 52, 53)49.054 ± 20.451544.460 ± 23.2789
6 months (n = 49, 47)23.676 ± 11.915234.183 ± 16.4667
Change from baseline to Month 6 (n= 48, 47)-24.646 ± 13.9893-8.362 ± 15.3852
SecondaryChange From Baseline in Urine NTx at 2 Months

The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

Time frame:
Baseline and 2 months
Reported as:
Mean · nM BCE/mM Cr
Change From Baseline in Urine NTx at 2 Months
nM BCE/mM CrZoledronic AcidRaloxifene
Baseline (n= 52, 53)49.054 ± 20.451544.460 ± 23.2789
At Month 2 (n= 54, 50)17.774 ± 9.110740.756 ± 23.3700
Change from baseline to Month 2 (n= 52, 50)-31.065 ± 16.4960-4.000 ± 11.2757
SecondaryChange From Baseline in Urine NTx at 4 Months

The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

Time frame:
Baseline and 4 months
Reported as:
Mean · nM BCE/mM Cr
Change From Baseline in Urine NTx at 4 Months
nM BCE/mM CrZoledronic AcidRaloxifene
Baseline (n= 52 , 53)49.054 ± 20.451544.460 ± 23.2789
At Month 4 (n= 48, 46)20.802 ± 13.163238.143 ± 24.9307
Change from baseline to Month 4 (n= 47, 46)-27.832 ± 15.4142-3.920 ± 17.1348
SecondaryChange From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months
Time frame:
Baseline and 2 months
Reported as:
Mean · U/L
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months
U/LZoledronic AcidRaloxifene
Baseline (n= 50, 48)30.104 ± 10.886827.094 ± 9.4039
At Month 2 (n= 51, 51)20.855 ± 5.849926.424 ± 7.8699
Change from baseline to Month 2 (n= 47, 46)-8.947 ± 6.4181-1.085 ± 4.0969
SecondaryChange From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months
Time frame:
Baseline and 4 months
Reported as:
Mean · U/L
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months
U/LZoledronic AcidRaloxifene
Baseline (n= 50, 48)30.104 ± 10.886827.094 ± 9.4039
At Month 4 (n= 49, 47)18.218 ± 5.184625.111 ± 8.4530
Change from baseline to Month 4 (n= 45, 42)-11.442 ± 7.8097-2.000 ± 5.0356
SecondaryChange From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months
Time frame:
Baseline and 6 months
Reported as:
Mean · U/L
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months
U/LZoledronic AcidRaloxifene
Baseline (n= 50, 48)30.104 ± 10.886827.094 ± 9.4039
At Month 6 (n= 51, 47)19.237 ± 5.518124.981 ± 7.9932
Change from baseline to Month 6 (n= 47, 42)-10.572 ± 7.3263-2.250 ± 7.1307
SecondaryOverall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire

The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

Time frame:
Immediately after infusion procedure
Reported as:
Number · Participants
Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire
ParticipantsZoledronic AcidRaloxifene
Not at all / A little00
Somewhat31
Quite23
Completely1611
Missing3338
SecondaryOverall Nurse Satisfaction Assessed by Satisfaction Questionnaire

The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

Time frame:
Immediately after infusion procedure
Reported as:
Number · Participants
Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire
ParticipantsZoledronic AcidRaloxifene
Not at all / A little / Somewhat00
Quite43
Completely2935
Missing2115
SecondaryOverall Patient Satisfaction Assessed by Satisfaction Questionnaire

Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

Time frame:
Immediately after infusion procedure
Reported as:
Number · Participants
Overall Patient Satisfaction Assessed by Satisfaction Questionnaire
ParticipantsZoledronic AcidRaloxifene
Not at all11
A little01
Somewhat11
Quite97
Completely4342
Missing01
SecondaryPatient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens

At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: "once a year i.v. infusion," "once daily pill," or "both are equal."

Time frame:
At 6 month visit
Reported as:
Number · Participants
Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens
ParticipantsZoledronic AcidRaloxifene
Once a year intravenous infusion4746
Once daily pill34
Both are equal33
Missing10

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Zoledronic Acid—1/56 (1.8%)31/56 (55.4%)
Raloxifene—1/53 (1.9%)13/53 (24.5%)
Most frequent serious events
Most frequent serious events
EventZoledronic AcidRaloxifene
Gastric ulcer haemorrhageGastrointestinal disorders0/561/53
Herpes zosterInfections and infestations1/560/53
Most frequent other events
Showing 10 of 15
Most frequent other events
EventZoledronic AcidRaloxifene
NauseaGastrointestinal disorders7/561/53
PyrexiaGeneral disorders6/560/53
DiarrhoeaGastrointestinal disorders5/561/53
SinusitisInfections and infestations4/564/53
PainGeneral disorders4/560/53
Urinary tract infectionInfections and infestations4/562/53
ArthralgiaMusculoskeletal and connective tissue disorders4/562/53
MyalgiaMusculoskeletal and connective tissue disorders4/563/53
ConstipationGastrointestinal disorders1/563/53
ChillsGeneral disorders3/561/53

Baseline characteristics

Age Continuous
Age Continuous(years)Zoledronic AcidRaloxifeneTotal
Mean58.8 ± 6.9761.5 ± 8.2060.1 ± 7.68
Age, Customized
Age, Customized(participants)Zoledronic AcidRaloxifeneTotal
Between 45 and 65 years433578
>=65 years131831
Sex: Female, Male
Sex: Female, Male(Participants)Zoledronic AcidRaloxifeneTotal
Female5653109
Male000
Post-menopausal
Post-menopausal(year)Zoledronic AcidRaloxifeneTotal
Mean12.5 ± 8.9413.4 ± 9.1713.0 ± 9.03
08

Study locations

17 sites
  • Women's Health Research
    Phoenix, Arizona 85015, United States
  • Associated Pharma Research Center
    Buena Park, California 90620, United States
  • Washington, District of Columbia 20036, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Women's Physicians of Jacksonville
    Jacksonville, Florida 32256, United States
  • Tampa Clinical Research
    Tampa, Florida 33624, United States
  • Springfield Clinic
    Springfield, Illinois 62703, United States
  • Consultants in Women's Health Care
    St Louis, Missouri 63131, United States
  • Alegent Health
    Omaha, Nebraska 68152, United States
  • Specialty Medical and Research Center
    Pahrump, Nevada 89048, United States
  • UMDNJ-Robert Wood Johnson Medical Center
    New Brunswick, New Jersey 08901, United States
  • Columbia University
    New York, New York 10032, United States
  • Kernodle Clinic, Inc.
    Burlington, North Carolina 27215, United States
  • The Portland Clinic
    Portland, Oregon 97205, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Texas Institute for Clinical Research
    Fort Worth, Texas 76104, United States
  • Valley Women's Health Clinic
    Renton, Washington 98055, United States
09

References and documents

Publications

  • Bachmann G, Kriegman A, Goncalves J, Kianifard F, Warren M, Simon JA. Effect of zoledronic acid compared with raloxifene on bone turnover markers in postmenopausal women with low bone density. Menopause. 2011 Aug;18(8):851-6. doi: 10.1097/gme.0b013e31820b80f1. PubMed 21796066 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00431444
Lead sponsor
Novartis
First posted
Feb 5, 2007
Start date
Jan 2007
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Mar 11, 2011
Last update
Mar 29, 2011

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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