Phase 2 Osteoporosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Women who are older than 40 and up to 65 years of age at the screening visit
- People with a body mass index (a measure of weight relative to height) between 18 and 35
- People who have confirmed menopause, either by having had no periods naturally for 12 or more consecutive months with a negative pregnancy test, or by having had no periods for 6 or more months with a specific hormone level result (FSH above 30 mIU/L) and a negative pregnancy test
- People who experience moderate to severe hot flushes or night sweats, with at least 14 of these episodes per week in the 7 days before joining the trial
Who may not be able to join:
- People who currently use or have previously used hormone replacement therapy (HRT), although certain vaginal oestrogen products may be permitted if paused at least 2 weeks before joining, and menopausal hormone therapy may be permitted if paused at least 6 weeks before joining (confirm with trial site)
- People who have a current or previous cancer diagnosis, except for a type of minor skin cancer called basal cell carcinoma
- People who have a known BRCA gene mutation (a gene linked to increased cancer risk)
- People who currently have an overactive thyroid gland
- People who have been diagnosed with osteoporosis (weakened or brittle bones)
- People who have a major mental health diagnosis or are currently taking medication for mental health conditions, such as antidepressants known as SSRIs
- People who have a known heart rhythm condition called prolonged QT, other significant heart rhythm abnormalities, or who take medications that can affect heart rhythm (such as sotalol, dronedarone, amiodarone, methadone, or certain antipsychotic medicines)
- People who have previously had a heart attack or heart failure
- People who have previously had a blood clot in a vein or artery (a thromboembolic event)
- People who currently use opioid pain medicines or blood-thinning medications, or who are unwilling to pause fish oil or omega-3 supplements for 3 days before certain study visits
- People who currently have alcohol or drug dependency issues
- People whose high blood pressure requires more than two medications to manage
- People with a serious history of severe allergic reactions or intolerances to medications
- People with moderate to severe liver or kidney disease (confirm with trial site)
- People who have been diagnosed with type 1 or type 2 diabetes
- People with long-term conditions that require immune-suppressing treatments, such as rheumatoid arthritis, inflammatory bowel disease, or vasculitis
- People who have known uterine fibroids, endometriosis, lupus (SLE), a hearing condition called otosclerosis, severe migraines, or sleep apnoea
- People who have known epilepsy, or a history of seizures or convulsions
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Martin Blomberg Jensen, D.M.Sc., Herlev Hospital
Phone: +45 38 68 63 64
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in bone remodeling from baseline to week 8.; Change in bone remodeling from baseline to week 8.; Change in bone remodeling from baseline to week 8
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.