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CompletedNCT00081653Updated Jul 14, 2017Results posted

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

A Phase 4 interventional study of ibandronate [Bonviva/Boniva] and ibandronate [Bonviva/Boniva] in Post-Menopausal Osteoporosis, sponsored by Hoffmann-La Roche. Completed at 31 sites in 14 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2017-07-14.

Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
719
Allocation
Randomized
Sex
Female
01

Study summary

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

02

Conditions studied

  • Post-Menopausal Osteoporosis
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 719 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • successful completion of Bonviva study BM16549, with at least 75% compliance;
  • ambulatory.

Exclusion criteria

Exclusion Criteria:

  • malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
  • breast cancer diagnosed within the previous 22 years.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
719 participants (actual)

Study arms

  • Experimental
    1

    Drug: ibandronate [Bonviva/Boniva]

  • Active comparator
    2

    Drug: ibandronate [Bonviva/Boniva]

Interventions

  • Drugibandronate [Bonviva/Boniva]

    150mg po monthly for 3 years

  • Drugibandronate [Bonviva/Boniva]

    100mg po monthly for 3 years

06

What researchers measure

Primary outcomes

  1. Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD

    Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).

    Time frame: Baseline and Months 12, 24 and 36

  2. Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)

    BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).

    Time frame: Baseline and Months 12, 24 and 36

Secondary outcomes

  1. Absolute Change From Baseline in Mean Total Hip BMD

    BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

    Time frame: Baseline and 12, 24 and 36 months

  2. Relative Percent Change From Baseline in Mean Total Hip BMD

    BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

    Time frame: Baseline, 12, 24 and 36 months

  3. Absolute Change From Baseline of Trough Serum CTX

    CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.

    Time frame: Baseline, 6, 12, 24 and 36 months

  4. Relative Percent Change From Baseline of Trough Serum CTX

    CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.

    Time frame: Baseline, 6,12, 24 and 36 months

07

Results

Posted Jul 21, 2009

Participant flow

Patients were recruited from 31 centers over the period of 18 May 2004 to 28 November 2007.

Participant flow — Overall Study
MilestoneIbandronate 100 Milligrams (mg)Ibandronate 150 mg
Started358361
Completed311324
Not completed4737
Withdrew: Adverse event2317
Withdrew: Lost to follow-up24
Withdrew: Refused treatment1814
Withdrew: Low bone mineral density10
Withdrew: Bone loss20
Withdrew: Participant leaving country10
Withdrew: Loss of bone mass02

Outcome measures

SecondaryAbsolute Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

Time frame:
Baseline and 12, 24 and 36 months
Reported as:
Mean · g/cm^2
Absolute Change From Baseline in Mean Total Hip BMD
g/cm^2Ibandronate 100 mgIbandronate 150 mg
Baseline (n=345,348)0.7680 ± 0.10930.7862 ± 0.1112
Month 12 (n=347,346)0.7669 ± 0.10970.7888 ± 0.1116
Change from Baseline at Month 12 (n=344,345)-0.0004 ± 0.02040.0025 ± 0.0200
Month 24 (n=322,336)0.7686 ± 0.11040.7882 ± 0.1124
Change from Baseline at Month 24 (n=319,335)-0.0010 ± 0.02270.0031 ± 0.0214
Month 36 (n=301,321)0.7663 ± 0.11330.7834 ± 0.1128
Change from Baseline at Month 36 (n=298,320)-0.0061 ± 0.0254-0.0030 ± 0.0252
SecondaryRelative Percent Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

Time frame:
Baseline, 12, 24 and 36 months
Reported as:
Mean · percent change in BMD
Relative Percent Change From Baseline in Mean Total Hip BMD
percent change in BMDIbandronate 100 mgIbandronate 150 mg
Change from Baseline at Month 12 (n=344,345)-0.0169 ± 2.85820.3459 ± 2.5849
Change from Baseline at Month 24 (n=319,335)-0.1092 ± 3.10400.4378 ± 2.8062
Change from Baseline at Month 36 (n=298,320)-0.8045 ± 3.3448-0.3496 ± 3.3254
SecondaryAbsolute Change From Baseline of Trough Serum CTX

CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.

Time frame:
Baseline, 6, 12, 24 and 36 months
Reported as:
Mean · ng/mL
Absolute Change From Baseline of Trough Serum CTX
ng/mLIbandronate 100 mgIbandronate 150 mg
Baseline (n= 56,68)0.232 ± 0.15200.219 ± 0.1799
Month 6 Postdose (n=56,68)0.176 ± 0.18260.126 ± 0.1222
Change from Baseline at Month 6 Postdose (n=55,67)-0.055 ± 0.1307-0.093 ± 0.1510
Month 12 (n=57,67)0.279 ± 0.16170.208 ± 0.1073
Change from Baseline at Month 12 (n=56,67)0.048 ± 0.1303-0.011 ± 0.1406
Month 24 (n=54,65)0.309 ± 0.14060.266 ± 0.1548
Change from Baseline at Month 24 (n=53,65)0.088 ± 0.12030.048 ± 0.1607
Month 36 (n=51,60)0.410 ± 0.18050.380 ± 0.2036
Change from Baseline at Month 12 (n=50,60)0.205 ± 0.13960.174 ± 0.1549
PrimaryAbsolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD

Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).

Time frame:
Baseline and Months 12, 24 and 36
Reported as:
Mean · g/cm^2
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
g/cm^2Ibandronate 100 mgIbandronate 150 mg
Baseline (n=347,346)0.7916 ± 0.08140.7977 ± 0.0791
Month 12 (n=347,346)0.7977 ± 0.08310.8069 ± 0.0819
Change from Baseline at Month 12 (n=346,343)0.0061 ± 0.02930.0097 ± 0.0289
Month 24 (n=323,336)0.8048 ± 0.08610.8111 ± 0.0852
Change from Baseline at Month 24 (n=322,333)0.0131 ± 0.03320.0140 ± 0.0356
Month 36 (n=308,320)0.8090 ± 0.09160.8155 ± 0.0892
Change from Baseline at Month 36 (n=307, 318)0.0172 ± 0.03820.0194 ± 0.0383
PrimaryRelative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)

BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).

Time frame:
Baseline and Months 12, 24 and 36
Reported as:
Mean · percent change
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
percent changeIbandronate 100 mgIbandronate 150 mg
Change from Baseline at Month 12 (n=346,343)0.8348 ± 3.81181.2550 ± 3.6402
Change from Baseline at Month 24 (n=322,333)1.6921 ± 4.23851.7865 ± 4.5058
Change from Baseline at Month 36 (n=307,318)2.1794 ± 4.91762.4322 ± 4.8146
SecondaryRelative Percent Change From Baseline of Trough Serum CTX

CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.

Time frame:
Baseline, 6,12, 24 and 36 months
Reported as:
Mean · percent change
Relative Percent Change From Baseline of Trough Serum CTX
percent changeIbandronate 100 mgIbandronate 150 mg
Baseline (n=56,68)0.232 ± 0.15200.219 ± 0.1799
Month 6 Postdose (n=56, 67)0.176 ± 0.182633.109 ± 40.3544
Change from Baseline at Month 6 Postdose (n=55,67)-24.622 ± 43.4212-33.109 ± 40.3544
Month 12 (n=57,67)0.279 ± 0.16170.208 ± 0.1073
Change from Baseline at Month 12 (n=56,67)31.121 ± 58.983225.125 ± 86.5607
Month 24 (n=54,65)0.309 ± 0.14060.266 ± 0.1548
Change from Baseline at Month 24 (n=53,65)58.657 ± 65.312853.704 ± 74.9810
Month 36 (51,60)0.410 ± 0.18050.380 ± 0.2036
Change from Baseline at Month 36 (n=50,60)121.106 ± 97.9878138.502 ± 125.7590

Adverse events

Collected over Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ibandronate 100 mg—68/358 (19%)187/358 (52.2%)
Ibandronate 150 mg—70/361 (19.4%)185/361 (51.2%)
Most frequent serious events
Showing 10 of 132
Most frequent serious events
EventIbandronate 100 mgIbandronate 150 mg
Myocardial infarctionCardiac disorders5/3581/361
Angina pectorisCardiac disorders0/3585/361
OsteoarthritisMusculoskeletal and connective tissue disorders4/3585/361
Ankle fractureInjury, poisoning and procedural complications1/3584/361
Wrist fractureInjury, poisoning and procedural complications3/3581/361
Back painMusculoskeletal and connective tissue disorders3/3580/361
CataractEye disorders3/3582/361
Radius fractureInjury, poisoning and procedural complications0/3583/361
CystoceleReproductive system and breast disorders0/3583/361
Femur fractureInjury, poisoning and procedural complications2/3580/361
Most frequent other events
Most frequent other events
EventIbandronate 100 mgIbandronate 150 mg
HypertensionVascular disorders42/35849/361
NasopharyngitisInfections and infestations46/35840/361
Back painMusculoskeletal and connective tissue disorders32/35836/361
ArthralgiaMusculoskeletal and connective tissue disorders32/35831/361
HypercholesterolaemiaMetabolism and nutrition disorders30/35823/361
Urinary tract infectionInfections and infestations22/35827/361
BronchitisInfections and infestations24/35821/361
OsteoarthritisMusculoskeletal and connective tissue disorders19/35824/361
InfluenzaInfections and infestations22/35815/361
Pain in extremityMusculoskeletal and connective tissue disorders18/35815/361

Baseline characteristics

Intent -To - Treat (ITT) population: All participants who were randomized into this study, received at least one dose of the trial medication, and had at least one follow-up efficacy data point (BMD or serum C-terminal peptide cross-links of Collagen Type I \[CTX\]).

Age, Continuous
Age, Continuous(years)Ibandronate 100 mgIbandronate 150 mgTotal
Mean67.8 ± 6.5567.7 ± 6.867.7 ± 6.7
Sex: Female, Male
Sex: Female, Male(Participants)Ibandronate 100 mgIbandronate 150 mgTotal
Female358361719
Male000
BMI (kg/m^2)
BMI (kg/m^2)(kg/m^2)Ibandronate 100 mgIbandronate 150 mgTotal
Mean25.87 ± 4.95726.04 ± 3.97625.96 ± 4.489
Race, Customized
Race, Customized(participants)Ibandronate 100 mgIbandronate 150 mgTotal
Caucasian/White341338679
Black011
Oriental011
Hispanic172037
Other011
08

Study locations

31 sites
  • Loma Linda, California 92357, United States
  • Lakewood, Colorado 80260, United States
  • Omaha, Nebraska 68131, United States
  • Livingston, New Jersey 07039, United States
  • Portland, Oregon 97213, United States
  • Liege, 4020, Belgium
  • Merksem, 2170, Belgium
  • Sao Paulo, 04026-000, Brazil
  • Plzen, 305 99, Czechia
  • Praha, 128 00, Czechia
  • Aalborg, 9000, Denmark
  • Ballerup, 2750, Denmark
  • Vejle, 7100, Denmark
  • Lyon, 69000, France
  • Berlin, 12200, Germany
  • Hannover, 30167, Germany
  • Balatonfuered, 8230, Hungary
  • Budapest, 1036, Hungary
  • Budapest, 1083, Hungary
  • Kiskunhalas, 6400, Hungary
  • Zalaegerszeg, 8900, Hungary
  • Siena, 53100, Italy
  • Leon, 37000, Mexico
  • Obregon, 85100, Mexico
  • Haugesund, 5507, Norway
  • Stavanger, 4010, Norway
  • Krakow, 31-501, Poland
  • Warszawa, 04-730, Poland
  • Barcelona, 08907, Spain
  • Madrid, 28041, Spain
  • Southampton, SO16 6YD, United Kingdom
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00081653
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 21, 2004
Start date
May 2004
Primary completion
Nov 2007
Completion
May 2008
Results posted
Jul 21, 2009
Last update
Jul 14, 2017

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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