Collagen boost: a new hope for fragile bones?
NCT ID NCT07347236
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking a daily collagen supplement (PROTÉGEN Plus) for 12 weeks helps older adults aged 60+ recover better from a fragility fracture. Participants will be split into two groups: one gets collagen plus standard care, the other gets standard care alone. Researchers will check nutrition, muscle mass, and bone health over 24 weeks to see if collagen speeds up recovery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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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60 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: * Male or female participants aged 60 years and above. * History of a fragility fracture (e.g., hip, wrist, or vertebral fracture) sustained within the past 12 months. * Registered outpatient at Hospital Sultan Abdul Aziz Shah (HSAAS). * Malaysian citizen. * Able to communicate in Bahasa Malaysia or English. * Able and willing to provide written informed consent. * Cognitive function score \>4 on the Elderly Cognitive Assessment Questionnaire (ECAQ). * Currently undergoing a structured rehabilitation programme. * May be receiving antiresorptive osteoporosis therapy or not receiving any osteoporosis pharmacological treatment at the time of recruitment. Exclusion Criteria: * Cognitive impairment, defined as ECAQ score ≤4 * Metabolic bone diseases other than osteoporosis (e.g., Paget's disease, osteomalacia). * Severe endocrine or metabolic disorders affecting bone metabolism (e.g., primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, hypogonadism, acromegaly). * Terminal illness or palliative care needs (e.g., advanced cancer, end-stage organ failure, late-stage neurodegenerative diseases). * Known allergy to fish, seafood, or collagen supplements, or diagnosis of phenylketonuria. * Kidney disease, including history of kidney stones or chronic kidney disease stage 4-5 (estimated glomerular filtration rate \<44 mL/min/1.73 m²). * Participation in another interventional study that may interfere with the study protocol. * Use of nutritional supplements during the study period. * Prior use of collagen or amino acid-based supplements within the past 6 months. * Non-ambulatory status prior to the fracture. * Unstable medical conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction, unstable angina, uncontrolled hypertension, pulmonary embolism). * Current use of anabolic osteoporosis therapy. * Alcohol dependence or active alcoholism.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia
Serdang, Selangor, 43400, Malaysia
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