Phase 2 Osteoporosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 65 years or older at the time of screening.
• People with a Body Mass Index (a measure of body weight relative to height) below 30.
• People identified as "pre-frail" based on a recognised frailty assessment, meaning they meet 1 or 2 out of 5 specific signs of physical decline — including reduced hand grip strength (based on gender and body size), slow walking speed (based on height and gender), frequent feelings of exhaustion, unintentional weight loss of 3 kilograms or more (or more than 5% of body weight) in the past year, or very low levels of physical activity.
• People who are able to walk 6 metres in a single attempt without help, or using only a simple aid such as a walking cane.
• People who are medically stable enough to attend check-up visits every 4 weeks and take part in all study activities.
• People who are willing to share existing test results from within the past 90 days, including bone density scans and blood or urine test results.
• People with enough mental clarity to understand the study and sign a consent form, or who have a legal representative to assist them with this.
• People who are willing to keep their usual diet and exercise habits during the study, and not start intense exercise programs or take large amounts of nutritional supplements.

Who may not be able to join:

• People who have had a serious sudden illness — such as a heart attack, pneumonia, or stroke — within the 2 weeks before screening.
• People with significant problems affecting major organs, including poor kidney function, abnormal liver enzyme levels, severe heart failure (grade III or IV), or severe lung disease requiring ongoing oxygen therapy (confirm with trial site for specific test thresholds).
• People who were unexpectedly hospitalised within the month before screening, or who had major surgery within the past 3 months and have not fully recovered.
• People currently being treated for cancer, or who finished cancer treatment less than 12 months ago.
• People who have used supplements containing certain ingredients — including HMB, creatine, branched-chain amino acids, or high-dose protein powder — within the 4 weeks before screening.
• People with a known allergy or sensitivity to any ingredients in the study supplements.
• People with moderate to severe dementia, severe depression, or other significant mental health conditions that would prevent them from cooperating with the study, unless a legal representative is available.
• People who have taken part in another clinical trial involving medicines, biological products, or nutritional supplements within the 3 months before screening.
• People who have recently started, or had a dose change to, medications that affect muscle or bone — such as steroids, anabolic steroids, testosterone, or growth hormones — within the 3 months before screening.
• People considered unsuitable for the study by the trial investigators due to safety or other concerns.

Important: Always verify eligibility with the trial site directly before applying.