An interventional study of 500 mg calcium from milk-derived minerals and Calcium Carbonate 500 MG in Osteopenia, Osteoporosis and Bone Health in Perimenopausal Women, sponsored by Cornell University. Not yet recruiting at 1 site in United States. Open to female participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Cornell University · Not applicable, Interventional, and Prevention
This study will compare adherence, tolerability, safety, and treatment satisfaction between a calcium-rich food and a traditional calcium carbonate supplement in women ages 40 to 90 who are at increased risk for osteoporosis. Participants will be randomly assigned to receive either a calcium-rich food providing 500 mg of calcium from milk-derived minerals or a 500 mg calcium carbonate supplement once daily for four weeks. Participants will complete brief weekly questionnaires assessing supplement use, gastrointestinal symptoms, and treatment satisfaction. The goal of the study is to determine whether the form in which calcium is consumed influences adherence and participant experience. No blood draws, imaging studies, or other invasive procedures are involved
Calcium intake is an important component of bone health and osteoporosis prevention. Despite widespread recommendations for calcium supplementation, long-term adherence to traditional calcium supplements is often poor because of gastrointestinal side effects, difficulty swallowing tablets, and dissatisfaction with conventional formulations. This study is designed to compare adherence, tolerability, safety, and treatment satisfaction between a calcium-rich food and a traditional calcium carbonate supplement in women at increased risk for osteoporosis.
Participants will be randomized in a 1:1 ratio to receive either a calcium-rich food providing 500 mg of calcium from milk-derived minerals or a 500 mg calcium carbonate supplement once daily for four weeks. Randomization will be administered using REDCap with blocked randomization (block size of four) and age stratification to ensure balanced allocation across age groups. A seven-day washout period without calcium supplements will precede study initiation. Participants will complete a baseline questionnaire followed by weekly questionnaires throughout the four-week intervention period.
The primary objective is to compare continuous adherence between study groups over the four-week intervention. Adherence will be calculated using measures of compliance and persistence derived from participants' weekly self-reported missed doses. The Morisky Medication Adherence Scale will also be collected as a secondary measure to support construct validity and comparison with prior osteoporosis research.
Secondary outcomes include gastrointestinal tolerability, treatment satisfaction, and safety. Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale, treatment satisfaction will be assessed using selected domains of the Treatment Satisfaction Questionnaire for Medication, and the frequency of gastrointestinal symptoms, including bloating and constipation, will be compared between study groups.
Eligible participants are women aged 40 to 90 years with either a family history of osteoporosis or a history of fracture who are willing to comply with study procedures and provide written informed consent. Individuals with medical conditions that would interfere with study participation, severe allergies to study ingredients, pregnancy, breastfeeding, dysphagia, or participation in another research study will be excluded.
The primary analysis will compare continuous adherence between groups using an independent two-sample t-test with a pre-specified Mann-Whitney U sensitivity analysis. Secondary outcomes will be analyzed using appropriate parametric or nonparametric statistical methods, with statistical significance defined as a two-sided p-value of less than 0.05
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 217 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.
Compared within Osteoporosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bone Diseases, Metabolic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria Female at birth, 40 to 90 years of age Family history of osteoporosis or history of fracture Willing and able to provide written Willing to comply with all study procedures Willing to refrain from making major dietary changes during the 4-week study No known allergy or intolerance to any study product ingredients Exclusion Criteria Medical condition that would interfere with study participation or adherence (including selected oncologic or psychiatric disorders) Known severe allergic reaction requiring an epinephrine auto-injector Pregnant, breastfeeding, or planning to become pregnant during the study Invasive medical procedure within the previous 3 months or planned during the study period Current participation in another research study or planning to participate during the study period Difficulty swallowing (dysphagia)
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will consume one calcium-rich food providing 500 mg of calcium from milk-derived minerals once daily for four weeks. The product will be supplied in unbranded packaging. Participants will complete baseline and weekly questionnaires assessing adherence, gastrointestinal tolerability, treatment satisfaction, and safety.
Other: 500 mg calcium from milk-derived minerals
Participants assigned to this arm will consume one 500 mg calcium carbonate supplement once daily with food for four weeks. Participants will complete baseline and weekly questionnaires assessing adherence, gastrointestinal tolerability, treatment satisfaction, and safety.
Dietary Supplement: Calcium Carbonate 500 MG
A calcium-rich food providing 500 mg of calcium from milk-derived minerals, consumed once daily for four weeks. The product also contains dates, milk protein concentrate, almonds, vitamin D from mushrooms, and white button mushrooms. Participants consume one serving daily with or without food. The product is supplied in unbranded packaging.
A commercially available calcium carbonate supplement providing 500 mg calcium, taken once daily with food for four weeks.
Continuous Adherence to Assigned Calcium Intervention
Measuring adherence to calcium intake
Time frame: 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS) Score
Gastrointestinal tolerability will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). Scores will be compared between study groups.
Time frame: 4 weeks
Treatment Satisfaction
Treatment satisfaction will be assessed using Questions 9, 10, and 14 of the Treatment Satisfaction Questionnaire for Medication (TSQM).
Time frame: 4 weeks
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request. All direct identifiers will be removed prior to sharing to protect participant confidentiality. Requests will be reviewed by the study investigators to ensure that the proposed use is scientifically appropriate and consistent with participant consent
Supporting information: Study protocol, Statistical analysis plan
Time frame: De-identified individual participant data, the study protocol, and the statistical analysis plan will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Access criteria: De-identified individual participant data, the study protocol, and the statistical analysis plan will be made available to qualified researchers upon reasonable request. Requests must include a scientifically sound research proposal and will be reviewed by the study investigators. Data will be shared under a data use agreement designed to protect participant confidentiality and comply with applicable institutional and regulatory requirements.
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