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Not Yet Recruiting
NCT07909304
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Conditions: Postmenopausal Osteoporosis
Sex: Female
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: Massachusetts General Hospital
Summary
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
Eligibility Criteria
Inclusion Criteria:
1. Women age \> 45
2. Postmenopausal by either of the following criteria:
\> 36 months since last spontaneous menses \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years
3. High risk of fracture defined as one of the following:
Prior history of osteoporotic fracture, plus hip or spine BMD T-score \< -2.0 Hip or spine BMD T-score \< -2.5 10-year predicted fracture risk of ≥20% for major osteoporotic fracture or ≥3% for hip fracture (designated as "high risk of fracture" by osteoporosis guidelines)
Exclusion Criteria:
1. Current or past use in the 12 months of denosumab
2. Any prior exposure to romosozumab
3. Current or use in the past 3 months of estrogens or SERMs
4. Current or use in the past 6 months of oral bisphosphonates (BPs) if most recent duration of oral BP use is less than 3 years; or current or use in the past 12 months of oral BPs if most recent duration of oral BP use is 3 years or more
5. Current or use in the past 36 months of parenteral BPs
6. Current or use in the past 24 months of teriparatide or abaloparatide
7. Use of glucocorticoids for more than 14 days consecutively within the past 6 months
Source: ClinicalTrials.gov (NCT07909304). StuddyBuddy aggregates publicly available trial information.