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Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis

NCT ID: NCT07283887

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Denosumab

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

Group Type ACTIVE_COMPARATOR

Denosumab

Intervention Type DRUG

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

Romosozumab

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

Group Type ACTIVE_COMPARATOR

Romosozumab

Intervention Type DRUG

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

Romosozumab plus denosumab

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

Group Type EXPERIMENTAL

Denosumab

Intervention Type DRUG

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

Romosozumab

Intervention Type DRUG

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

Interventions

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Denosumab

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

Intervention Type DRUG

Romosozumab

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shau-Huai Fu, PhD

Role: CONTACT

[email protected]
+886972655734

Facility Contacts

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Shau-Huai Fu, PhD

Role: primary

[email protected]
0972655734

Role: backup

[email protected]

Other Identifiers

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202509047MINA

Identifier Type: -

Identifier Source: org_study_id