Post-Menopausal OsteopeniaPhase 4NCT00129623
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
A Phase 4 study testing ibandronate [Bonviva/Boniva] in people with Post-Menopausal Osteopenia, run by Hoffmann-La Roche at 12 sites in United States.
Trial summary
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Post-Menopausal Osteopenia
- What is being tested?
- ibandronate [Bonviva/Boniva]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2005to Dec 2007
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women 45-60 years of age;
- post-menopausal;
- ambulatory.
Who cannot join
- vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
- low-trauma osteoporotic fracture in any other bone;
- breast cancer diagnosed within last 20 years;
- other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
- treatment with any bisphosphonate within last 2 years;
- treatment with other drugs affecting bone metabolism within last 6 months.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Amarillo, Texas, 79124
Study site
Bethesda, Maryland, 20817
Study site
Cincinnati, Ohio, 45224
Study site
Detroit, Michigan, 48236
Study site
Lakewood, Colorado, 80227
Study site
Norfolk, Virginia, 23502
Study site
Omaha, Nebraska, 68131
Study site
Portland, Oregon, 97213
Study site
Richmond, Virginia, 23294
Study site
St Louis, Missouri, 63110
Study site
Stuart, Florida, 34996
About this study
Official title: Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
- Conditions
- Post-Menopausal Osteopenia
- Being tested
- Placebo, ibandronate [Bonviva/Boniva]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
po monthly for 1 year
ibandronate [Bonviva/Boniva]Drug
150mg po monthly for 1 year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bonviva/Boniva] |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)
Measured: Baseline and Month 12
Secondary outcomes (8)
Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.
Measured: Baseline and Month 12
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12
BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.
Measured: Baseline and Month 12
Absolute Change From Baseline in BMD of the Proximal Femur at Month 12
BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.
Measured: Baseline and Month 12
Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)
Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
Measured: Baseline and 3, 6 and 12 months
Absolute Change From Baseline in sCTX
Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
Measured: Baseline and 3, 6, 12 months
Percentage of Responders
Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.
Measured: Up to 12 months
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Measured: Up to 15 days after end of study treatment (Approximately 2 years)
Number of Participants With Marked Laboratory Abnormalities
Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].
Measured: Screening up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionDec 2007
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 Post-Menopausal OsteopeniaStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129623
- Sponsor's protocol ID
- BA18492
- Status last verified
- Dec 2015
- First submitted
- 11 Aug 2005
- Last updated
- 11 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia
- ClinicalTrials.gov ID
- NCT00129623
- Acronym / sponsor ID
- BA18492
- Conditions
- Post-Menopausal Osteopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Aug 2005 (estimated)
- Results
- Posted 11 Jan 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 evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. 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 |
|---|---|---|
| 1 | Experimental | Drug: ibandronate [Bonviva/Boniva] |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women 45-60 years of age;
- post-menopausal;
- ambulatory.
Key exclusion criteria (6 listed)
- vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
- low-trauma osteoporotic fracture in any other bone;
- breast cancer diagnosed within last 20 years;
- other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
- treatment with any bisphosphonate within last 2 years;
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 1 year | Drug | 2 |
| ibandronate [Bonviva/Boniva]150mg po monthly for 1 year | Drug | 1 |
Primary outcome
Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
Time frame: Baseline and Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)
8 secondary outcomes
Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12
Time frame: Baseline and Month 12
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12
Time frame: Baseline and Month 12
Absolute Change From Baseline in BMD of the Proximal Femur at Month 12
Time frame: Baseline and Month 12
Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)
Time frame: Baseline and 3, 6 and 12 months
Absolute Change From Baseline in sCTX
Time frame: Baseline and 3, 6, 12 months
Percentage of Responders
Time frame: Up to 12 months
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 15 days after end of study treatment (Approximately 2 years)
Number of Participants With Marked Laboratory Abnormalities
Time frame: Screening up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-Menopausal Osteopenia
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
RecruitingObservational study
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy
Gynecological Malignancies, Menopausal Symptoms
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
12 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 [Bonviva/Boniva] in people with Post-Menopausal Osteopenia, run by Hoffmann-La Roche at 12 sites in United States.
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 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 11 Jan 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?
Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) 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 11 Jan 2016.