Phase 2 Osteoporosis Trial, Recruiting

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

Who might be able to join this trial:

• You are a woman between 60 and 75 years old, of any ethnicity.
• A bone density scan (DXA scan) done within the last 6 months shows your bone strength is lower than normal but not yet at the level of osteoporosis (a T-score between lower than -1.0 and higher than -2.5).
• You are able to understand the study information and agree to take part on your own.

Who may not be able to join:

• You have been diagnosed with osteoporosis, have had a hip fracture, or have had a spinal fracture confirmed by a recent bone scan (within 6 months).
• You have had a bone fracture caused by a minor injury (such as a fall from standing height) in the last 6 months.
• You have a health condition that makes walking or weight-bearing exercise difficult, such as recent surgery or limited mobility.
• You have poor wound healing or a long-lasting open wound.
• You have a condition called primary hyperparathyroidism (an overactive parathyroid gland).
• You have a known severe vitamin D deficiency, unless this has been treated and re-tested.
• You have a known condition that affects bone health, such as an overactive thyroid that is not controlled, severe kidney disease, reduced liver function, active inflammatory joint disease, coeliac disease, severe lung disease (COPD), or certain hormone disorders (confirm with trial site).
• You have taken bone-strengthening or bone-protecting medications in the last 5 years.
• You have used anabolic steroids, bone-protecting therapy, or supplements known to affect bones in the past year.
• You have Type 1 or Type 2 diabetes.
• You have severe heart failure that significantly limits your daily activity (confirm with trial site).
• You are currently taking certain medications that affect how a drug called everolimus is processed by the body — a detailed list of these medications includes Ketoconazole, Itraconazole, Clarithromycin, Rifampicin, Carbamazepine, Phenytoin, and several others (confirm the full list with the trial site).
• You have a blood clotting disorder or need long-term blood-thinning medication.
• Your blood test results show low red blood cells (anaemia), low white blood cells, low neutrophils (a type of infection-fighting cell), or low platelets (confirm specific levels with trial site).
• You have poorly controlled cholesterol or triglyceride (blood fat) levels above certain thresholds, especially combined with a family history of high cholesterol (confirm with trial site).
• You are scheduled to receive treatment that suppresses the immune system (such as for an organ transplant) or are due to receive chemotherapy or other cancer treatment.
• You have a significant problem with your immune system, either from birth or due to another condition.
• You have unstable heart disease.
• You have a known allergy to rapamycin or similar drugs (called rapalogs).
• You are unable to speak and understand Danish, or are unable to cooperate with the study requirements.

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