Combining two medications for treating postmenopausal osteoporosis
Combined Anabolic Therapy Study
PHASE4 · Massachusetts General Hospital · NCT06558188
This study is testing whether combining two approved medications can help women over 45 with postmenopausal osteoporosis improve their bone health and lower their risk of fractures.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | romosozumab |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06558188 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two FDA-approved medications, Romosozumab and Teriparatide, on women suffering from postmenopausal osteoporosis. The study aims to determine the efficacy of these combined anabolic therapies in improving bone health and reducing fracture risk. Participants will be closely monitored to assess the outcomes of the treatment regimen over time. The trial is designed for women aged 45 and older who are at high risk for fractures due to osteoporosis.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 45 and older who have osteoporosis and are at high risk for fractures.
Not a fit: Patients with significant previous use of bone health modifying treatments or those with other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve treatment options for women with postmenopausal osteoporosis, potentially reducing their risk of fractures.
How similar studies have performed: Other studies have shown promising results with similar anabolic treatment approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Benjamin Leder, MD — MGH
- Study coordinator: Aparna Patnaik, BA
- Email: apatnaik1@mgh.harvard.edu
- Phone: 617-726-6129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoporosis, Postmenopausal, Osteoporosis