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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ronacaleret | Subjects receiving ronacaleret (200mg,300mg or 400mg) in study CR9108963 will be enrolled into this study. |
| |
| Placebo | Subjects receiving placebo in study CR9108963 will be enrolled into this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DXA | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) | 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in BMD, as measured by DXA, at the total hip, trochanter and femoral neck | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ballerup Municipality | 2750 | Denmark | |||
| GSK Investigational Site |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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|
| 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 | 12 to 18 months from the month 6 CR9108963 DXA to the CR9112792 study visit |
| Bergen |
| 5094 |
| Norway |
| GSK Investigational Site | Hamar | 2317 | Norway |
| D009750 |
| Nutritional and Metabolic Diseases |