CompletedPhase 4

The Effect of Effervescent Alendronate on Bone Turnover

Denmark64 participantsStarted 2021-10-01

Plain-language summary

64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 2 years since last menstrual bleeding * Bone mineral density T-score \< -1 at either lumbar spine or hip * CTx \> 0.42 µg/L Exclusion Criteria: * Ever treatment for osteoporosis * Indication for teriparatide treatment * Treatment with oral systemic glucocorticoids within last 12 months * Rheumatoid arthritis * Inflammatory bowel disease * Untreated thyroid disease * Primary hyperparathyroidism * Diabetes mellitus * eGFR \< 60 mL/min * Cancer within last 2 years except basal cell carcinoma of the skin * Hormone therapy * Unstable liver disease * Contraindications for alendronate * Major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery). * Vitamin D \< 50nmol/L

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CTx

Timeframe: baseline to week 16

Trial details

NCT IDNCT05325515

SponsorAarhus University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Osteopenia or Osteoporosis trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.