Summary
Calcium + Vitamin D has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Osteoporosis. ClinicalTrials.gov lists 8 registered trials linking Calcium + Vitamin D to Osteoporosis: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00887354). The largest enrolment is 448 participants (NCT05060406). Registration activity spans 2003 to 2019. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2015 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
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 | 65.0 (trials 30.0, literature 30.0, tier 5, approved bonus 0.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 randomised controlled trial publications) |
| Agent type | Supplement |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00887354 | A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture 2009 | completed | Phase 4 | 224 |
| NCT00271713 | Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D) 2006 | completed | Phase 4 | 70 |
| NCT00824993 | Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients 2008 | completed | Phase 3 | 78 |
| NCT02629341 | Functional Yogurt Powder Effect on Bone Health Biomarkers 2015 | completed | Phase 3 | 79 |
| NCT00054418 | Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer 2003 | completed | Phase 3 | 216 |
| NCT05060406 | A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture 2019 | status unknown | Phase 3 | 448 |
| NCT00321932 | Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant 2005 | completed | Phase 2 | 61 |
| NCT01857154 | A Study of Changes in Bone Mineral Density as a Function of Consuming Two Different Forms of Calcium Carbonate 2013 | status unknown | Not applicable | 160 |
Published literature
- Cochrane review Risk factors for osteoporosis in rheumatoid arthritis patients: a meta-analysisFu T, Zhang R, Yue L et al. · Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026 · PMID 41188646
- Cochrane review Effects of Combined Exercise and Calcium/Vitamin D Supplementation on Bone Mineral Density in Postmenopausal Women: A Systematic Review and Meta-AnalysisBai J, Huang W, Yan R et al. · Nutrients · 2025 · PMID 41470812
- Meta-analysis Clinical presentation, risk factors and management of pregnancy-associated osteoporosis: a systematic review and meta-analysisOrhadje E, Makaram N, Berg K et al. · Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025 · PMID 40205203
- Meta-analysis Anti-osteoporotic drug efficacy for periprosthetic bone loss after total hip arthroplasty: A systematic review and network meta-analysisHatano M, Koizumi Y, Yamamoto N et al. · Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association · 2025 · PMID 38342711
- Clinical trial publication One versus 2 years of alendronate following denosumab: the CARD extensionTsai JN, Jordan M, Lee H et al. · Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024 · PMID 39112628
- Cochrane review Etidronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal womenWells GA, Hsieh SC, Peterson J et al. · The Cochrane database of systematic reviews · 2024 · PMID 38591743
- Meta-analysis Comparative Effectiveness of Therapeutic Interventions in Pregnancy and Lactation-Associated Osteoporosis: A Systematic Review and Meta-analysisAnagnostis P, Lampropoulou-Adamidou K, Bosdou JK et al. · The Journal of clinical endocrinology and metabolism · 2024 · PMID 37708365
- Cochrane review Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal womenWells GA, Hsieh SC, Zheng C et al. · The Cochrane database of systematic reviews · 2022 · PMID 35502787
- Cochrane review Impact of magnesium on bone health in older adults: A systematic review and meta-analysisGroenendijk I, van Delft M, Versloot P et al. · Bone · 2022 · PMID 34666201
- Clinical trial publication A Dairy Product to Reconstitute Enriched with Bioactive Nutrients Stops Bone Loss in High-Risk Menopausal Women without Pharmacological TreatmentMorato-Martínez M, López-Plaza B, Santurino C et al. · Nutrients · 2020 · PMID 32722015
- Clinical trial publication Bone mineral density and osteoporosis in heart transplanted patients: A single-center retrospective study at Skåne University Hospital in Lund 1988-2016Löfdahl E, Söderlund C, Rådegran G · Clinical transplantation · 2019 · PMID 30618200
- Clinical trial publication Effects of denosumab on bone mineral density in Japanese women with osteoporosis treated with aromatase inhibitors for breast cancerNakatsukasa K, Koyama H, Ouchi Y et al. · Journal of bone and mineral metabolism · 2019 · PMID 29520506
- Clinical trial publication Effects of Daily Intake of Calcium and Vitamin D-Enriched Milk in Healthy Postmenopausal Women: A Randomized, Controlled, Double-Blind Nutritional StudyReyes-Garcia R, Mendoza N, Palacios S et al. · Journal of women's health (2002) · 2018 · PMID 29676968
- Randomized controlled trial The effect of nitrogen containing bisphosphonates, zoledronate and alendronate, on the production of pro-angiogenic factors by osteoblastic cellsIshtiaq S, Edwards S, Sankaralingam A et al. · Cytokine · 2015 · PMID 25461393
- Randomized controlled trial A calcium-collagen chelate dietary supplement attenuates bone loss in postmenopausal women with osteopenia: a randomized controlled trialElam ML, Johnson SA, Hooshmand S et al. · Journal of medicinal food · 2015 · PMID 25314004
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 Calcium + Vitamin D approved for Osteoporosis?
Calcium + Vitamin D 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 Calcium + Vitamin D in clinical trials for Osteoporosis?
ClinicalTrials.gov lists 8 registered trials linking Calcium + Vitamin D to Osteoporosis: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00887354). The largest enrolment is 448 participants (NCT05060406). Registration activity spans 2003 to 2019.
What does the evidence show for Calcium + Vitamin D in Osteoporosis?
Calcium + Vitamin D has both completed registered trials and synthesis-level publications linked to Osteoporosis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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.