Optimal Meals to Reduce Bone Resorption in Women With Osteopenia (NCT07056322) | Clinical Trial Compass
By InvitationNot Applicable
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Denmark13 participantsStarted 2025-12-01
Plain-language summary
The goal of this clinical trial is to investigate whether different types of small meals can help reduce bone loss in postmenopausal women with osteopenia, a condition where bone density is lower than normal and may lead to osteoporosis.
The main hypothesis is:
\- A small amount of dairy (100 ml) is just as effective as a larger meal containing dairy and banana in reducing bone resorption.
Based on this, the study aims to answer the following questions:
\- Which type and size of meal is most effective in reducing bone resorption?
Researchers will compare five different types of meals to a fasting control day to determine which meals best reduce markers of bone loss in the blood.
Participants will attend six clinical visits: five involving the intake of different test meals, and one control visit involving fasting. The participants will have blood samples taken over a period of 6 hours after each meal or fasting period to measure markers of bone metabolism.
This study aims to identify a simple, non-drug-based strategy to support bone health and help prevent progression to osteoporosis.
Who can participate
Age range
80 Years
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:
* Osteopenia at the lumbar spine defined as BMD t-score -2.4 to -1.1.
* Postmenopausal women
* Age \< 80 years
* CTX level ≥ 0.40 ng/ml
* BMI 17-25 kg/m2
Exclusion Criteria:
* A diagnosis of osteoporosis, diabetes, primary hyperparathyroidism or active malignancy.
* Current or recent (within two years) use of systemic glucocorticoids for 4 continuous weeks or more, anticonvulsants or anti-osteoporotic drugs including systemic estrogen treatment.
* Low p-25-OH vitamin D-levels (\< 50 pmol/l)
* Estimated glomerular filtration (eGFR) \<60 ml/min
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
1
Bone resoroption
Timeframe: From enrollment through six study visits over a period of approximately 12 weeks