Anabolic Therapy in Postmenopausal Osteoporosis

In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: Romosozumab; Drug: Denosumab

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Postmenopausal women at high risk of fracture

Exclusion Criteria:

• Prior therapy exclusions

  1. current use or use in the past 12 months of oral bisphosphonates or denosumab
  2. current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
  3. use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
  4. any current or previous use of romosozumab or strontium
  5. current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.

Other exclusions

1. Confirmed serum alkaline greater than 2 times the upper normal limit.
2. Stage 4 or 5 chronic kidney disease (GFR less than 30)
3. Hypercalcemia (Ca greater than 10.5 mg/dL)
4. Hypocalcemia (Ca less than 8.8 mg/dL)
5. Elevated blood PTH (intact PTH greater than 77 pg/mL)
6. Serum 25-OH vitamin D less than 20 ng/mL
7. HCT less than 32%.
8. History of malignancy (except basal cell carcinoma).
9. Significant pulmonary disease
10. History of myocardial infarction or stroke within the preceding year.
11. History of unstable angina or transient ischemic attack in the past year.
12. Current atrial fibrillation.
13. Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
14. Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
15. 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.
16. Uncontrolled eczema
17. Congenital or acquired bone disease other than osteoporosis.
18. Known sensitivity to denosumab or any of its excipients.
19. Known sensitivity to romosozumab or any of its excipients.
20. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Romosozumab and denosumab	Drug: Romosozumab; Monthly romosozumab; Drug: Denosumab; Every 6 months denosumab
Active Comparator: Romosozumab	Drug: Romosozumab; Monthly romosozumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hip areal bone mineral density	Change in total hip bone density between month 0 and month 12	Month 0 to 12

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Benjamin Leder, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Osteoporosis; Nutritional and Metabolic Diseases; Osteoporosis, Postmenopausal; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Denosumab; romosozumab
• Other Study ID Numbers: 2021P002125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes