Anabolic Therapy in Postmenopausal Osteoporosis
1 other identifier
interventional
50
1 country
1
Brief Summary
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2022
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedStudy Start
First participant enrolled
March 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
April 15, 2026
April 1, 2026
5.5 years
August 12, 2021
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total hip areal bone mineral density
Change in total hip bone density between month 0 and month 12
Month 0 to 12
Study Arms (2)
Romosozumab and denosumab
ACTIVE COMPARATORRomosozumab
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women at high risk of fracture
You may not qualify if:
- 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.
- 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)
- Elevated blood PTH (intact PTH greater than 77 pg/mL)
- Serum 25-OH vitamin D less than 20 ng/mL
- HCT less than 32%.
- History of malignancy (except basal cell carcinoma).
- Significant pulmonary disease
- History of myocardial infarction or stroke within the preceding year.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Leder BZ, Ramchand SK, Jordan M, Ryan S, Patnaik A, Lee H, Tsai JN. 3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Mar;14(3):216-222. doi: 10.1016/S2213-8587(25)00319-5. Epub 2026 Jan 29.
PMID: 41621431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Leder, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 12, 2021
First Posted
August 18, 2021
Study Start
March 24, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04