Postmenopausal OsteoporosisPhase 4NCT00545051
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
A Phase 4 study testing ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 15 sites in Finland.
Trial summary
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- ibandronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 15 sitesFinland
- Study dates
- May 2006to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-menopausal women, 50-85 years of age;
- any inflammatory rheumatoid disease including polymyalgia rheumatica;
- receiving treatment with 5-15 mg/day of prednisolone.
Who cannot join
- previous treatment with an iv bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
- treatment with parathyroid hormone in last 2 years;
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- history of major gastrointestinal disease.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Finland15 sites
Study site
Hämeenlinna, 13530
Study site
Helsinki, 00100
Study site
Helsinki, 00290
Study site
Helsinki, 00350
Study site
Hyvinkää, 05800
Study site
Jyväskylä, 10100
Study site
Jyväskylä, 40100
Study site
Kuopio, 70211
Study site
Lahti, 15110
Study site
Oulu, 90029
Study site
Oulu, 90100
Study site
Tampere, 33100
Study site
Tampere, 33101
Study site
Turku, 20100
Study site
Vantaa, 01300
About this study
Official title: A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Placebo, ibandronate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
po monthly for 12 months
ibandronateDrug
Also called Bonviva/Boniva
150mg po monthly for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate | Experimental | Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months. Receives: Drug: ibandronate |
| Placebo | Placebo comparator | Participants received monthly oral placebo for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.
Measured: Baseline and Month 12
Secondary outcomes (4)
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6
Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.
Measured: Baseline and Month 6
Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12
Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.
Measured: Baseline and Months 6 and 12
Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12
Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.
Measured: Baseline and Months 1, 6 and 12
Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months
Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545051
- Sponsor's protocol ID
- ML20088
- Status last verified
- Apr 2016
- First submitted
- 16 Oct 2007
- Last updated
- 12 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT00545051
- Acronym / sponsor ID
- ML20088
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate | Experimental | Drug: ibandronateParticipants received monthly oral ibandronate (150 milligrams [mg]) for 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received monthly oral placebo for 12 months. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- post-menopausal women, 50-85 years of age;
- any inflammatory rheumatoid disease including polymyalgia rheumatica;
- receiving treatment with 5-15 mg/day of prednisolone.
Key exclusion criteria (6 listed)
- previous treatment with an iv bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
- treatment with parathyroid hormone in last 2 years;
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebopo monthly for 12 months | Drug | Placebo |
| ibandronateAlso: Bonviva/Boniva150mg po monthly for 12 months | Drug | Ibandronate |
Primary outcome
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Time frame: Baseline and Month 12
Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.
4 secondary outcomes
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6
Time frame: Baseline and Month 6
Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12
Time frame: Baseline and Months 6 and 12
Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12
Time frame: Baseline and Months 1, 6 and 12
Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 15 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.