Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis

NCT07283887 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 202509047MINA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is a lifelong chronic condition requiring long-term management. Conventional first-line anti-resorptive therapies often yield slow BMD improvement and may plateau after years of treatment. Recent AACE/ACE guidelines recommend anabolic agents as initial therapy in patients with severe osteoporosis or very high fracture risk; however, even anabolic monotherapy may be insufficient, with many patients failing to reach a T-score ≥ -2.5. To address this unmet need, we propose a pilot study exploring cyclic treatment using romosozumab combined with denosumab, compared with standard denosumab monotherapy. In addition to monitoring biochemical bone markers and BMD, we will incorporate imaging feature extraction from X-rays and AI-based radiomic analysis to identify imaging biomarkers that may support precision treatment strategies. This single-center, open-label, 6-month, randomized pilot trial will enroll 90 postmenopausal women with osteoporosis (T-score ≤ -2.5) at NTUH Yunlin Branch, randomized 1:1:1 into three arms: denosumab alone, romosozumab alone, or combined therapy. The primary endpoint is percent change in lumbar spine BMD at 6 months; secondary outcomes include hip and femoral neck BMD, bone turnover markers (CTX, P1NP), fracture incidence, and adverse events. Results will estimate effect size and synergy to inform future large-scale RCTs and clinical application.

Conditions

Osteoporosis

Keywords

romosozumab; denosumab; combination therapy

Outcome Measures

Primary Outcomes (1)

• 6-Month Percentage Change in PA Spine BMD

  Percentage change from baseline in PA spine BMD at 6 months

  6 months

Secondary Outcomes (4)

• 6-Month Percentage Change in femoral neck BMD

  6 months

• 6-Month Percentage Change in total hip BMD

  6 months

• Percentage Change in Serum CTX at 6 Months

  6 months

• Percentage Change in Serum P1NP at 6 Months

  6 months

Other Outcomes (5)

• Changes in Bone Metabolism Markers

  6 months

• Radiographic Changes at Hip and Spine

  6 months

• Incidence of Clinical Osteoporotic Fractures

  6 months

Study Arms (3)

Denosumab

ACTIVE COMPARATOR

After study entry, a single dose of denosumab will be administered for a six-month duration.

Drug: Denosumab

Romosozumab

ACTIVE COMPARATOR

After study entry, romosozumab will be administered monthly for six months.

Drug: Romosozumab

Romosozumab plus denosumab

EXPERIMENTAL

After study entry, a single dose of denosumab will be administered. Romosozumab will be given monthly for six months.

Drug: Denosumab; Drug: Romosozumab

Interventions

Denosumab DRUG

After study entry, a single dose of denosumab will be administered for a six-month duration.

Denosumab; Romosozumab plus denosumab

Romosozumab DRUG

After study entry, romosozumab will be administered monthly for six months.

Romosozumab; Romosozumab plus denosumab

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women over 50 years of age eligible for osteoporosis treatment, defined as having a bone mineral density (BMD) T-score ≤ -2.5 at the lumbar spine, total hip, or femoral neck, and who have never received osteoporosis medications (including both injectable and oral agents); or those who have used oral osteoporosis medications for no more than six months and have discontinued them for at least three months; or those who have previously received injectable osteoporosis drugs but have discontinued them for more than two years.

You may not qualify if:

• Age \>80 years; continuous corticosteroid use; secondary osteoporosis; current use of medications affecting bone metabolism; ongoing hormone replacement therapy; metabolic bone disorders; active cancer; hypocalcemia; continued use of any osteoporosis treatment without an adequate washout period; contraindications to denosumab; and contraindications to romosozumab, such as a history of myocardial infarction or stroke within the past year.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan, 640, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab; romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shau-Huai Fu, PhD

CONTACT

+886972655734; b90401045@gmail.com

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: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 16, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)