NCT05010590Active, not recruitingPhase 4
Anabolic Therapy in Postmenopausal Osteoporosis
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 12 Aug 2021
- Start date
- 24 Mar 2022
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT05010590
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- From 24 Mar 2022 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy exclusions
- current use or use in the past 12 months of oral bisphosphonates or denosumab
- current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
- use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
- any current or previous use of romosozumab or strontium
- current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.
- Other exclusions
Other illness
- History of malignancy (except basal cell carcinoma).
- Significant pulmonary disease
- History of myocardial infarction or stroke within the preceding year.
- History of unstable angina or transient ischemic attack in the past year.
- Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
- Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Congenital or acquired bone disease other than osteoporosis.
- History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.
Lab values
- Confirmed serum alkaline greater than 2 times the upper normal limit.
- Stage 4 or 5 chronic kidney disease (GFR less than 30)
- Hypercalcemia (Ca greater than 10.5 mg/dL)
- Hypocalcemia (Ca less than 8.8 mg/dL)
- Serum 25-OH vitamin D less than 20 ng/mL
Other
- Elevated blood PTH (intact PTH greater than 77 pg/mL)
- HCT less than 32%.
- Current atrial fibrillation.
- Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Uncontrolled eczema
- Known sensitivity to denosumab or any of its excipients.
- Known sensitivity to romosozumab or any of its excipients.
Who the study is looking for
- Postmenopausal women at high risk of fracture
Age in the registry: 45 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
Related publications
- 3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial.Lancet Diabetes Endocrinol · 2026 · PMID 41621431
This page is information, not medical advice. Discuss any trial with your doctor.