An interventional study of Augmented-Fracture Liaison Service Arm and Enhanced Usual Care Arm in Osteoporosis, Osteoporotic Fractures and Fragility Fracture, sponsored by University of Alabama at Birmingham. Recruiting at 23 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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Among 14 studies in Osteoporosis by University of Alabama at Birmingham — 1 open to participants now, 1 under way, none of them phase 3. Osteoporosis · University of Alabama at Birmingham.
Among the 14 studies in Osteoporosis by University of Alabama at Birmingham, this one is the 5th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2024, is one of 8 with no phase, and was the 14th registered.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
Browse Osteoporosis studies →1 of the 14 studies in Osteoporosis by University of Alabama at Birmingham is open now, in 1 country.
By country, each count listing its studies:
Of the 132 Osteoporosis studies recruiting now, 76 (58%) set no upper age limit and 20 (15%) stop at 75 or younger; 9 take children under 18; 36 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 2,634 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Median enrollment 1,009 across the 11 interventional studies, 200 across the 3 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
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University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Osteoporosis by University of Alabama at Birmingham, from their registry updates:
Nothing recorded among them since 2026-09-25.
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RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be mailed education materials and encouraged to follow up with their primary care physician.
Behavioral: Enhanced Usual Care Arm
Participants will be mailed education materials. Participants will also be contacted by patient navigators who will guide participants through the process of getting a Bone Health Clinician appointment.
Behavioral: Augmented-Fracture Liaison Service Arm
Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
Patients will be mailed education materials and encouraged to follow up with their primary care physician.
Incidence of subsequent fracture
Incidence of fracture 24 months post randomization
Time frame: 24 months post randomization
Plan to share: Yes — Anonymized data will be made available upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Study protocol, SAP, and ICF will be made available upon request at conclusion of the study and after study scientific reports (e.g. abstracts, journal articles) are published.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Jun 2029, 53 months after the start.
Of 219 non-industry interventional studies with no phase under Osteoporosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 49. This study's planned 53 months is above that.
Counting every sponsor, half of 238 studies reached it within 26 months; a quarter within 9 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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University of Alabama at Birmingham →