OsteoporosisNCT00891553
CR9112792, a Follow-up of Study CR9108963
An observational study of Osteoporosis, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether bone mineral density has increased in a subgroup of postmenopausal osteoporotic women from study CR9108963, between 6 and 12 months following cessation of ronacaleret therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- DXA
- Type of treatment
- Surgery or procedure
- How many people
- 171 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2009to Jun 2009
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population for CR9112792 will include approximately 145 postmenopausal women of those enrolled in study CR9108963, identified from subjects willing to participate and meeting eligibility criteria at pre-specified sites.
Who may be able to join
- Informed consent: Subject is willing and able to provide written informed consent.
- Subjects: Subjects must have completed through the Month 12 visit of study CR9108963, or have had an early withdrawal visit on or after their Month 10 visit.
- DXA: Subjects must have either a final evaluable spine or hip DXA scan in CR9108963 as confirmed by Synarc, taken within 4 weeks of the last dose of study medication.
- Study medication: Subjects must have been on placebo or ronacaleret 200mg, 300mg or 400mg for ≥299 days in study CR9108963.
Who cannot join
- Any treatment with a PTH-based therapy or strontium ranelate after discontinuation of treatment in study CR9108963.
- Chronic systemic corticosteroid [e.g., glucocorticoid, mineralocorticoid] treatment of more than 2 intra-articular injections within the past year or use of oral, parenteral, or long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid will not exclude the subject from participating.
- Treatment with any topical corticosteroid will not exclude the subject from participation.
- Treatment with fluoride (dose greater than 10mg/day) for osteoporosis after discontinuation of treatment in study CR9108963.
- Administration of any investigational drug after discontinuation of treatment in study CR9108963.
- Subject who, in the opinion of the investigator, is unfit for this study or unable to comply with the requirements of the protocol.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Norway2 sites
GSK Investigational Site
Bergen, 5094
GSK Investigational Site
Hamar, 2317
About this study
Official title: Study CR9112792, a Study to Assess Bone Mineral Density Changes in Post-menopausal Osteoporotic Women Following Discontinuation of Ronacaleret or Placebo Treatment in Study CR9108963
The purpose of this study is to determine whether bone mineral density has increased in a subgroup of postmenopausal osteoporotic women from study CR9108963, between 6 and 12 months following cessation of ronacaleret therapy.
Read the detailed description
CR9112792 is a follow-up study of CR9108963, the 12 month dose ranging study of ronacaleret (SB-751689), a calcium sensing receptor antagonist, in postmenopausal women with osteoporosis. CR9108963 evaluated the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability in comparison with placebo and 2 active comparators, alendronate and teriparatide. CR9108963 was terminated earlier than planned due to an observed lack of efficacy in lumbar spine and hip BMD. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with ronacaleret to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy. Subjects at pre-specified sites from the CR9108963 placebo, 200mg, 300mg and 400mg dose groups will be included in this study.
- Conditions
- Osteoporosis
- Being tested
- DXA
- Keywords
- bone mineral density, calcium-sensing receptor antagonist, ronacaleret, postmenopausal osteoporosis
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXAProcedure or surgery
CR9112792 is a follow-up study of CR9108963, in which the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability were evaluated in comparison with placebo and 2 active comparators, alendronate and teriparatide. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with placebo or ronacaleret (200mg, 300mg, 400mg) to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy, evaluating lumbar spine and hip BMD by DXA. There is no administration of drug in this study.
| Study group | Role | What they receive |
|---|---|---|
| Ronacaleret | Subjects receiving ronacaleret (200mg,300mg or 400mg) in study CR9108963 will be enrolled into this study. Receives: Procedure: DXA | |
| Placebo | Subjects receiving placebo in study CR9108963 will be enrolled into this study. Receives: Procedure: DXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4)
Measured: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit
Secondary outcomes (3)
Percent change in BMD, as measured by DXA, at the total hip, trochanter and femoral neck
Measured: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck
Measured: 16 to 25 months from the screening CR9108963 DXA to the CR9112792 study visit
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck
Measured: 12 to 18 months from the month 6 CR9108963 DXA to the CR9112792 study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891553
- Sponsor's protocol ID
- 112792
- Status last verified
- Feb 2013
- First submitted
- 23 Apr 2009
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study CR9112792, a Study to Assess Bone Mineral Density Changes in Post-menopausal Osteoporotic Women Following Discontinuation of Ronacaleret or Placebo Treatment in Study CR9108963
- ClinicalTrials.gov ID
- NCT00891553
- Acronym / sponsor ID
- 112792
- Conditions
- Osteoporosis
- Keywords
- bone mineral density, calcium-sensing receptor antagonist, ronacaleret, postmenopausal osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 May 2009 (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 purpose of this study is to determine whether bone mineral density has increased in a subgroup of postmenopausal osteoporotic women from study CR9108963, between 6 and 12 months following cessation of ronacaleret therapy.
Detailed description
CR9112792 is a follow-up study of CR9108963, the 12 month dose ranging study of ronacaleret (SB-751689), a calcium sensing receptor antagonist, in postmenopausal women with osteoporosis. CR9108963 evaluated the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability in comparison with placebo and 2 active comparators, alendronate and teriparatide. CR9108963 was terminated earlier than planned due to an observed lack of efficacy in lumbar spine and hip BMD. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with ronacaleret to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy. Subjects at pre-specified sites from the CR9108963 placebo, 200mg, 300mg and 400mg dose groups will be included in this study.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ronacaleret | – | Procedure: DXASubjects receiving ronacaleret (200mg,300mg or 400mg) in study CR9108963 will be enrolled into this study. |
| Placebo | – | Procedure: DXASubjects receiving placebo in study CR9108963 will be enrolled into this study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population for CR9112792 will include approximately 145 postmenopausal women of those enrolled in study CR9108963, identified from subjects willing to participate and meeting eligibility criteria at pre-specified sites.
Key inclusion criteria (4 listed)
- Informed consent: Subject is willing and able to provide written informed consent.
- Subjects: Subjects must have completed through the Month 12 visit of study CR9108963, or have had an early withdrawal visit on or after their Month 10 visit.
- DXA: Subjects must have either a final evaluable spine or hip DXA scan in CR9108963 as confirmed by Synarc, taken within 4 weeks of the last dose of study medication.
- Study medication: Subjects must have been on placebo or ronacaleret 200mg, 300mg or 400mg for ≥299 days in study CR9108963.
Key exclusion criteria (6 listed)
- Any treatment with a PTH-based therapy or strontium ranelate after discontinuation of treatment in study CR9108963.
- Chronic systemic corticosteroid [e.g., glucocorticoid, mineralocorticoid] treatment of more than 2 intra-articular injections within the past year or use of oral, parenteral, or long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid will not exclude the subject from participating.
- Treatment with any topical corticosteroid will not exclude the subject from participation.
- Treatment with fluoride (dose greater than 10mg/day) for osteoporosis after discontinuation of treatment in study CR9108963.
- Administration of any investigational drug after discontinuation of treatment in study CR9108963.
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 |
|---|---|---|
| DXACR9112792 is a follow-up study of CR9108963, in which the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability were evaluated in comparison with placebo and 2 active comparators, alendronate and teriparatide. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with placebo or ronacaleret (200mg, 300mg, 400mg) to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy, evaluating lumbar spine and hip BMD by DXA. There is no administration of drug in this study. | Procedure or surgery | Placebo, Ronacaleret |
Primary outcome
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4)
Time frame: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit
3 secondary outcomes
Percent change in BMD, as measured by DXA, at the total hip, trochanter and femoral neck
Time frame: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck
Time frame: 16 to 25 months from the screening CR9108963 DXA to the CR9112792 study visit
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck
Time frame: 12 to 18 months from the month 6 CR9108963 DXA to the CR9112792 study visit
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 25 Feb 2013.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by GlaxoSmithKline at 3 sites in 2 countries.
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 4 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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) (time frame: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit). 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 25 Feb 2013.