Summary
Genistein (Soy isoflavone) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Osteoporosis. ClinicalTrials.gov lists 5 registered trials linking Genistein (Soy isoflavone) to Osteoporosis: 5 have completed. The most advanced is Phase 3 (NCT01463436). The largest enrolment is 203 participants (NCT00661856). Registration activity spans 1997 to 2010. No published literature item is linked to Genistein (Soy isoflavone) and Osteoporosis in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | C · Preliminary |
|---|---|
| Evidence score | 21.0 (trials 16.0, literature 0.0, tier 5, approved bonus 0.0) |
| Registered trials | 5 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 0 other |
| Linked publications | 0 |
| Agent type | Supplement (Nutraceutical) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Herbal and nutraceutical interventions for osteoporosis: a review of effects on bone mineral density · Halma M, O'Leary C, Varon J · 2025 |
| Data sources | OSMF Chronic Disease Review |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01463436 | The Effect of Soy Isoflavone Supplementation on Endothelial Function 2010 | completed | Phase 3 | 200 |
| NCT00000613 | CVD Risk and Health in Postmenopausal Phytoestrogen Users 1997 | completed | Phase 2 | — |
| NCT00244907 | Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women 2006 | completed | Phase 1 | 23 |
| NCT00661856 | Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices 2001 | completed | Not applicable | 203 |
| NCT00698984 | Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health 2007 | completed | Not applicable | 70 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: Herbal and nutraceutical interventions for osteoporosis: a review of effects on bone mineral density · Halma M, O'Leary C, Varon J · 2025.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Genistein (Soy isoflavone) approved for Osteoporosis?
Genistein (Soy isoflavone) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Osteoporosis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Genistein (Soy isoflavone) in clinical trials for Osteoporosis?
ClinicalTrials.gov lists 5 registered trials linking Genistein (Soy isoflavone) to Osteoporosis: 5 have completed. The most advanced is Phase 3 (NCT01463436). The largest enrolment is 203 participants (NCT00661856). Registration activity spans 1997 to 2010.
What does the evidence show for Genistein (Soy isoflavone) in Osteoporosis?
Genistein (Soy isoflavone) has 5 completed registered trials for Osteoporosis but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. 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.