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NCT06264609
Precision Medicine Approach for Osteoporosis - Follow Up Study
Phase 4 trial testing Alendronate in Osteoporosis in 40 participants. Enrolling by invitation.
31 December 2029
Quick facts
| Lead sponsor | Paul F Netzel |
|---|---|
| Phase | Phase 4 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 February 2024 |
| Primary completion | 31 December 2029 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alendronate — full drug profile →
- Teriparatide — full drug profile →
- Alendronate — full drug profile →
Conditions studied
- Osteoporosis — all drugs for Osteoporosis →
Sponsor
Paul F Netzel
Who can join
45 and older, female only, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality. Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem. Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06264609
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Osteoporosis
Currently open trials in the same condition.
- NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract · recruiting
- NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS) · NA · recruiting
- NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study · NA · recruiting
- NCT07281586 — Step-down Therapy After Long-term Osteoporosis Treatment · Phase 4 · recruiting
- NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06264609 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Paul F Netzel
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06264609.
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