Investigating treatments to prevent bone loss after Denosumab
The Optimal Sequential Therapy After Long Term Denosumab Treatment
This study is testing if two medications, Alendronate and Zoledronate, can help prevent bone loss in postmenopausal women and men over 50 who have been treated with Denosumab for osteoporosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | Denosumab |
| Locations | 1 site (Douliu, Yunlin County) |
| Trial ID | NCT05091099 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if Alendronate and Zoledronate can effectively prevent bone mineral density loss in patients who have undergone long-term treatment with Denosumab for osteoporosis. It employs a randomized trial design to assess the efficacy of these treatments following the withdrawal of Denosumab. The focus is on postmenopausal women and men over 50 years old who have received Denosumab for a specific duration. The outcomes will help inform optimal sequential therapy for osteoporosis management.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women or men over 50 years old who have been treated with Denosumab for at least two years but less than three years.
Not a fit: Patients with severe renal impairment, malignancies, or those on certain medications affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new strategy to maintain bone density in patients after stopping Denosumab treatment.
How similar studies have performed: While there have been studies on osteoporosis treatments, this specific sequential therapy approach following Denosumab withdrawal is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Postmenopausal women or men over 50 years old 2. Denosumab treatment for at least two years and less than three years (up to five doses). Exclusion Criteria: 1. Estimated glomerular filtration rate \<35 ml/min. 2. Malignancy 3. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism 4. Secondary osteoporosis 5. Metabolic bone diseases 6. Contraindications to ZOL 7. Patients older than 80 years old 8. Hypocalcemia
Where this trial is running
Douliu, Yunlin County
- National Taiwan University Hospital, Yunlin branch — Douliu, Yunlin County, Taiwan (Recruiting)
Study contacts
- Study coordinator: Shau-Huai Fu, Doctor
- Email: b90401045@gmail.com
- Phone: +886972655734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.