Summary
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Osteoporosis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Osteoporosis. ClinicalTrials.gov lists 2 registered trials linking Sirolimus to Osteoporosis: 2 are currently recruiting. The most advanced is Phase 2 (NCT07191353). The largest enrolment is 35000 participants (NCT06065852). Registration activity spans 2009 to 2025. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2012. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Osteoporosis ranks 221 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Bone density decline of 1-3%/year in postmenopausal women without treatment; fracture risk increases exponentially with T-score decline; no spontaneous remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 29.0 (trials 7.0, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 2 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADCY5 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT07191353 | Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women 2025 | recruiting | Phase 2 | 148 |
| NCT06065852 | National Registry of Rare Kidney Diseases 2009 | recruiting | Not applicable | 35,000 |
Published literature
- Clinical trial publication Use of alendronate sodium (Fosamax) to ameliorate osteoporosis in renal transplant patients: a case-control studyHuang WH, Lee SY, Weng CH et al. · PloS one · 2012 · PMID 23185261
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADCY5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sirolimus approved for Osteoporosis?
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Osteoporosis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Osteoporosis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sirolimus in clinical trials for Osteoporosis?
ClinicalTrials.gov lists 2 registered trials linking Sirolimus to Osteoporosis: 2 are currently recruiting. The most advanced is Phase 2 (NCT07191353). The largest enrolment is 35000 participants (NCT06065852). Registration activity spans 2009 to 2025.
What does the evidence show for Sirolimus in Osteoporosis?
Trials of Sirolimus in Osteoporosis are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADCY5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.