Combined Anabolic Therapy
Phase 4
Recruiting
- Conditions
- Osteoporosis, PostmenopausalOsteoporosis
- 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
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the anabolic effects of romosozumab and teriparatide in postmenopausal osteoporosis?
How does combined anabolic therapy compare to standard-of-care treatments like bisphosphonates in postmenopausal osteoporosis patients?
Which biomarkers are associated with response prediction to romosozumab and teriparatide combination therapy in postmenopausal osteoporosis?
What are the known adverse events and management strategies for romosozumab and teriparatide in treating postmenopausal osteoporosis?
Are there other FDA-approved combination therapies or competitor drugs targeting sclerostin and parathyroid hormone pathways for postmenopausal osteoporosis?
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital🇺🇸Boston, Massachusetts, United StatesAparna Patnaik, BAContact617-726-6129apatnaik1@mgh.harvard.edu