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:

• Women aged 50 to 80 years old who are able to walk around freely
• Women whose bone density scan (a type of scan called a DXA) shows a T-score between -4.0 and -2.5 at the spine, hip neck, or total hip — meaning bone density is low but not severely low
• Women who have at least one additional risk factor, such as: a past bone fracture caused by a minor fall or injury; a parent who had a hip fracture; higher-than-normal bone turnover detected during screening tests; low body weight; being aged 70 or older; or currently smoking
• Women who have gone through menopause, either naturally (no periods for more than 2 years) or after having both ovaries removed more than 2 years ago — or, in some cases, where a hormone test (FSH level above 40 mIU/mL) confirms menopause status

Who may not be able to join:

• People with bone or metabolic diseases
• People with conditions affecting the parathyroid glands (overactive or underactive)
• People with thyroid conditions (overactive or underactive thyroid)
• People with rheumatoid arthritis
• People with cancer (malignant tumours)
• People with conditions that affect the body's ability to absorb nutrients (malabsorption syndrome)
• People with liver cirrhosis, active hepatitis B or C, unstable liver disease, or certain abnormal liver blood test results
• People with severe kidney disease
• People who have had a significant heart or stroke-related event in the 12 months before screening, such as a heart attack, unstable chest pain, stroke, or serious heart failure — or who have certain blood disorders (confirm with trial site)
• People with abnormally high or low calcium levels in the blood
• People with vitamin D deficiency (a blood level of 25-hydroxyvitamin D below 20 ng/mL)
• People with current or past jaw bone infection or bone death (osteonecrosis of the jaw); active dental or jaw disease needing oral surgery; planned invasive dental surgery; or incomplete recovery from previous dental or oral surgery
• People who have received intravenous bisphosphonate medications (a type of bone treatment given by drip) within the past 2 years
• People who have taken oral bisphosphonate tablets for 2 years or more, or for between 3 months and 2 years with the last dose taken less than 1 year before screening
• People who have taken certain medications within the 6 weeks before screening that can affect bone, including: parathyroid hormone treatments (such as teriparatide); anabolic hormones or testosterone; higher-dose steroid medications used for more than 10 days; certain medications used for osteoporosis or menopause such as raloxifene, estrogen, progesterone, or tibolone; active vitamin D supplements used for more than 30 days in total; certain anti-seizure drugs, heparin, or other long-term medications such as lithium, methotrexate, or similar (confirm with trial site for full list); or certain traditional Chinese medicines used for osteoporosis (confirm with trial site for specific products)
• People who have had more than two fractures of the spinal (vertebral) bones

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