drugset / Trial / NCT00996801
MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been receiving oral bisphosphonate therapy for at least 3 years.
Timeline
- Start
- 2009-11
- Primary completion
- 2011-06
- Completion
- 2011-06
Publications
- Results Cosman F, Gilchrist N, McClung M, Foldes J, de Villiers T, Santora A, Leung A, Samanta S, Heyden N, McGinnis JP 2nd, Rosenberg E, Denker AE. A phase 2 study of MK-5442, a calcium-sensing receptor antagonist, in postmenopausal women with osteoporosis after long-term use of oral bisphosphonates. Osteoporos Int. 2016 Jan;27(1):377-86. doi: 10.1007/s00198-015-3392-7. Epub 2015 Nov 10.
- Saag K, Cosman F, De Villiers T, Langdahl B, Scott BB, Denker AE, Pong A, Santora AC. Early changes in bone turnover and bone mineral density after discontinuation of long-term oral bisphosphonates: a post hoc analysis. Osteoporos Int. 2021 Sep;32(9):1879-1888. doi: 10.1007/s00198-020-05785-3. Epub 2021 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alendronic Acid | Small molecule | 70 mg | Oral |
| Subject | Encaleret | Small molecule | 5 mg | Oral |
| Subject | Encaleret | Small molecule | 7.5 mg | Oral |
| Subject | Encaleret | Small molecule | 10 mg | Oral |
| Subject | Encaleret | Small molecule | 15 mg | Oral |
| Background | Calcium carbonate | Other / unclassified | 400 mg | Oral |
| Background | Calcium carbonate | Other / unclassified | 500 mg | Oral |
| Background | Cholecalciferol | Other / unclassified | 5600 iu | Oral |