How strong is the evidence for stem-cell therapy in Osteoporosis & Bone Health?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is thin and mostly exploratory: the registry holds 14 records, 5 completed, 0 at Phase 3 or 4, and 4 stopped early (29%). MSC-specific work accounts for 7 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Osteoporosis & Bone Health
The endpoint that matters is fracture incidence, with bone mineral density as a surrogate over at least two years. Short-term bone-marker changes move with vitamin D, calcium and activity, and say nothing about whether a bone will break.
What we can say from registrations alone
- Volume: 14 registered studies since 2005.
- Maturity: 0 confirmatory-phase records.
- Delivery: 5 completed; 4 terminated, withdrawn or suspended.
- Scale: median planned enrolment 37 participants, largest 35,000.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT00321932 — Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant | Phase 2 | Completed | 61 | University of Minnesota | 2005-07 |
| NCT03197623 — Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids | Phase 1 | Completed | 58 | Nancy E. Lane, MD | 2016-10-14 |
| NCT04488432 — Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant | n/a | Completed | 45 | University Hospital, Brest | 2019-11-27 |
| NCT03925532 — Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant | Phase 2 | Completed | 30 | Roswell Park Cancer Institute | 2019-12-19 |
| NCT02566655 — Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis | Phase 1 | Completed | 10 | Red de Terapia Celular | 2015-09 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Osteoporosis & Bone Health research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Osteoporosis & Bone Health?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is thin and mostly exploratory: 14 registered records, 0 at Phase 3/4 and 4 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
That has to be checked per product with the regulator that governs where you would be treated. A clinic's own claim of approval is not verification.
Why do clinics cite hundreds of studies?
Volume is the cheapest form of credibility. Ask instead for the controlled studies of the specific product, and read what outcome they measured.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.