OSTEOPOROSIS, POSTMENOPAUSALPhase 2NCT00351091
Risedronate in Postmenopausal Women With Low Bone Density
A Phase 2 study testing RISEDRONATE in people with OSTEOPOROSIS, POSTMENOPAUSAL, run by Sanofi.
Trial summary
The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of… Read more about this study
- Who is it for?
- Ages 65 to 80 years, women only
- Conditions the study is for
- OSTEOPOROSIS, POSTMENOPAUSAL
- What is being tested?
- RISEDRONATE
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jun 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- ambulatory women,postmenopausal >= 5 years
- have lumbar spine baseline BMD within the following criterion :
- Hologic: <= 0.827 g/cm2 or
- Lunar: <= 0.942 g/cm2 or
- Norland: <= 0.768 g/cm2
- be in general good health as determined by medical history, physical examination and laboratory tests
Who cannot join
- serum 25-OH vitamin D level <= 12 ng/ml
- history of osteomalacia
- history of active hyperparathyroidism or hyperthyroidism
- hypocalcemia or hypercalcemia from any cause
- depot injection >10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
- use of Vitamin D supplementation within 3 months prior to starting the investigational product
Show all 19Show fewer
- use of any of the following medications within a specified number of months prior to starting the investigational product :
- any bisphosphonate.
- use of any fluoride with the exception of fluoride use for oral hygiene
- strontium
- other bone active agents
- subcutaneous estrogen implant
- oral or parenteral glucocorticoids
- anabolic steroids
- estrogen or estrogen-related drugs, except for low dose vaginal creams
- progestogen
- calcitonin, calcitriol, or calcifediol
- any allergic or abnormal reaction to bisphosphonates
- creatinine clearance < 30 ml/min
About this study
Official title: a Six Month, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study to Estimate the Pharmacodynamic Response of Two Risedronate Regimens Compared With 5mg Daily : 150mg Monthly Dose for Six Months and 15mg Daily for Thirty Days Followed by 150mg Monthly Dose for 5 Months in Postmenopausal Women With Low Bone Density.
The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months
The secondary objectives are :
- To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
- To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate.
- To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
- To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.
- Conditions
- OSTEOPOROSIS, POSTMENOPAUSAL
- Being tested
- RISEDRONATE
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISEDRONATEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine NTX at week 4 of month 6
Secondary outcomes (1)
Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startNov 2002
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSTEOPOROSIS, POSTMENOPAUSALStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351091
- Sponsor's protocol ID
- HMR4003B_2501
- Status last verified
- Feb 2012
- First submitted
- 11 Jul 2006
- Last updated
- 17 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Six Month, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study to Estimate the Pharmacodynamic Response of Two Risedronate Regimens Compared With 5mg Daily : 150mg Monthly Dose for Six Months and 15mg Daily for Thirty Days Followed by 150mg Monthly Dose for 5 Months in Postmenopausal Women With Low Bone Density.
- ClinicalTrials.gov ID
- NCT00351091
- Acronym / sponsor ID
- HMR4003B_2501
- Conditions
- OSTEOPOROSIS, POSTMENOPAUSAL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Nov 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 12 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months
The secondary objectives are :
- To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
- To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate.
- To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
- To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- ambulatory women,postmenopausal >= 5 years
- have lumbar spine baseline BMD within the following criterion :
- be in general good health as determined by medical history, physical examination and laboratory tests
Key exclusion criteria (19 listed)
- serum 25-OH vitamin D level <= 12 ng/ml
- history of osteomalacia
- history of active hyperparathyroidism or hyperthyroidism
- hypocalcemia or hypercalcemia from any cause
- depot injection >10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
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 |
|---|---|---|
| RISEDRONATE | Drug | – |
Primary outcome
Urine NTX at week 4 of month 6
1 secondary outcome
Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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 Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RISEDRONATE in people with OSTEOPOROSIS, POSTMENOPAUSAL, run by Sanofi.
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 6 inclusion and 19 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 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urine NTX at week 4 of month 6. 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 17 Feb 2012.