New precision approach could revolutionize osteoporosis care
NCT ID NCT05151484
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a personalized treatment for age-related osteoporosis using the drug teriparatide. Researchers aim to match treatment to each patient's bone turnover rate using simple blood tests, avoiding the need for painful bone biopsies. The trial involves 60 adults aged 45 and older with osteoporosis who have not taken bone drugs before.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Teriparatide (a bone-building drug given as daily injections)
- What this could lead to
- If successful, this could lead to a non-invasive way to tailor osteoporosis treatment to each patient, potentially reducing fractures and hospitalizations.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. The treatment requires daily injections and carries risks like calcium imbalances.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures) 2. Treatment naive with respect to with anabolic or antiresorptive bone drugs. 3. Premenopausal, menopausal, and post-menopausal females. 4. 45 years old and older. 5. Presence or absence of diabetes 6. Normal levels of Vitamin D 7. Absence of all exclusion criteria on clinical workup Patients diagnosed as osteoporotic due to the presence of fragility fractures, but without osteoporotic t-scores, will not be included because they would require fractures as a study endpoint which would entail a multi-center approach. Moreover, abnormal bone quality has been shown to be present in these patients, which requires bone histology for assessment. Exclusion Criteria: 1. Pregnant or trying to become pregnant or are breastfeeding. 2. Participation in a study of an investigational drug during the past 30 days. 3. Treatment with anabolic or antiresorptive bone drugs. 4. Use of systemic anticoagulation (blood thinner) 5. Planned or anticipated oral surgery within the next 12 months. 6. Allergy to the antibiotics demeclocycline or tetracycline. 7. Planning to move out of the area within 18 months of the study. 8. Inability to stand or sit upright for at least 30 minutes. 9. Chronic alcoholism and/or drug addiction. 10. Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)). 11. Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 Diabetes Mellitus). 12. Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections). 13. Abnormalities of the esophagus (tube connecting the mouth to the stomach) which delay esophageal emptying such as stricture (narrowing) or achalasia (a condition that prevents normal swallowing). 14. Have other bone diseases that are not linked to age or menopause. 15. Have a history of malignancy (cancer), not including non-melanoma skin cancer. 16. Vitamin D (Calcidiol) level below the normal range (below 20ng/mL). 17. AFTER RANDOMIZATION: If randomized to Group 1 Teriparatide and radius BMD t-score is less than -3.5 and does not sign consent to continue in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Kentucky
Lexington, Kentucky, 40536, United States
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Other studies related to the condition(s) this trial covers.