Phase 3 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 who agree to take part in the study and sign a consent form.
• Women who have gone through menopause, are able to walk without assistance, and are between 50 and 85 years old (inclusive).
• People whose bone density scan results in the lower back or hip area show a T-score of -2.5 or lower, but higher than -4.0 (confirm with trial site for exact measurement details).
• People who have at least one of the following risk factors: a bone fracture caused by a minor injury after age 40; a parent who has had a hip fracture; higher-than-normal bone turnover detected during screening; low body weight (BMI of 19 or under); being aged 65 or older; or currently smoking.
• Women who have not had a natural period for more than 2 years, or who had both ovaries surgically removed more than 2 years ago — with confirmation of menopausal status through hormone testing if surgical history is unclear.

Who may not be able to join:

• People with a bone disease or condition affecting how the body processes minerals.
• People with a condition affecting the parathyroid glands (either overactive or underactive).
• People with a thyroid condition (either overactive or underactive).
• People with rheumatoid arthritis.
• People with a condition that affects the body's ability to absorb nutrients properly.
• People with severe kidney disease.
• People with low vitamin D levels (below 20 ng/mL on a specific blood test).
• People with current or past jaw bone disease or infection, an active dental or jaw condition requiring surgery, a planned invasive dental procedure, or who have not fully recovered from previous dental or oral surgery.
• People who have previously used a medication called denosumab.
• People who have used certain intravenous (injected) osteoporosis medications — including bisphosphonates, fluoride, or strontium — within the last 5 years.
• People who have taken oral bisphosphonate tablets for 3 years or more, or for between 3 months and 3 years if the last dose was taken less than 1 year before joining the study.
• People who have taken any medication known to affect bone health within 6 weeks before screening (confirm with trial site for the specific list of medications).
• People who have had more than two broken bones in the spine.
• People who have or have had a malignant tumour (cancer).

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