| NCT ID | NCT06558188 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Osteoporosis, Postmenopausal |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2025-02-03 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Benjamin Leder, MD
PRINCIPAL INVESTIGATOR
MGH
Frequently Asked Questions
Who can join the NCT06558188 clinical trial?
This trial is open to female participants only, aged 45 Years or older, studying Osteoporosis, Postmenopausal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06558188 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06558188 currently recruiting?
Yes, NCT06558188 is actively recruiting participants. Contact the research team at apatnaik1@mgh.harvard.edu for enrollment information.
Where is the NCT06558188 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06558188 clinical trial?
NCT06558188 is sponsored by Massachusetts General Hospital. The principal investigator is Benjamin Leder, MD at MGH. The trial plans to enroll 50 participants.