Combined Anabolic Therapy
Phase 4
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06558188
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
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Exclusion Criteria
- no significant previous use of bone health modifying treatments
- known congenital or acquired bone disease other than osteoporosis
- significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
- abnormal calcium or parathyroid hormone level
- serum vitamin D <20 ng/dL
- anemia (hematocrit <32%)
- history of malignancy (except non-melanoma skin carcinoma)
- excessive alcohol use or substance abuse
- known contraindications to romosozumab or teriparatide
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Romosozumab Romosozumab romosozumab Romosozumab and Teriparatide Romosozumab romosozumab and teriparatide Romosozumab and Teriparatide Teriparatide romosozumab and teriparatide
- Primary Outcome Measures
Name Time Method Lumbar spine areal bone mineral density Month 0 to 12 Change in lumbar spine bone density between month 0 and month 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States