OsteopeniaNCT07763509
Calcium-Rich Food Versus Calcium Carbonate for Bone Health
A study testing 500 mg calcium from milk-derived minerals and Calcium Carbonate 500 MG in people with Osteopenia and Osteoporosis, run by Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Osteoporosis, Bone Health in Perimenopausal Women
- What is being tested?
- 500 mg calcium from milk-derived minerals and Calcium Carbonate 500 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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 informed consent 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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Clinical and Translational Science Center, Weill Cornell Medical College
New York, New York, 10065
Jeff Zhu, jez2003@med.cornell.edu
About this study
Official title: Evaluating Adherence, Tolerability, and Safety of a Novel Oral Dietary Calcium Chew vs. Calcium Carbonate in Women 40-90: A Real-Life, Prospective, Randomized Controlled Trial
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
Read the detailed description
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
- Conditions
- Osteopenia, Osteoporosis, Bone Health in Perimenopausal Women, Menopause Related Conditions, Fracture Healing
- Being tested
- 500 mg calcium from milk-derived minerals, Calcium Carbonate 500 MG
- Keywords
- Osteoporosis, osteopenia, bone health, menopause, Fractures
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mg calcium from milk-derived mineralsOther
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.
Calcium Carbonate 500 MGDietary supplement
A commercially available calcium carbonate supplement providing 500 mg calcium, taken once daily with food for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calcium-Rich Food | Experimental | 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. Receives: Other: 500 mg calcium from milk-derived minerals |
| Calcium Carbonate Supplement | Active comparator | 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. Receives: Dietary Supplement: Calcium Carbonate 500 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Adherence to Assigned Calcium Intervention
Measuring adherence to calcium intake
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups for four weeks: a calcium-rich food providing 500 mg of calcium from milk-derived minerals, or a traditional 500 mg calcium carbonate supplement. Participants will remain in their assigned group for the duration of the study and will not cross over between interventions. Randomization will be administered in REDCap using blocked randomization and age stratification.
- Masking
- None (open label)
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Adrienne Bitar, Cornell University
- Investigators
- Jeff Zhu, Study director, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763509
- Sponsor's protocol ID
- 26-02-526-380
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Prince RL, Devine A, Dhaliwal SS, Dick IM. Effects of calcium supplementation on clinical fracture and bone structure: results of a 5-year, double-blind, placebo-controlled trial in elderly women. Arch Intern Med. 2006 Apr 24;166(8):869-75. doi: 10.1001/archinte.166.8.869.
PubMed 16636212Badamgarav E, Fitzpatrick LA. A new look at osteoporosis outcomes: the influence of treatment, compliance, persistence, and adherence. Mayo Clin Proc. 2006 Aug;81(8):1009-12. doi: 10.4065/81.8.1009. No abstract available.
PubMed 16901022Rondanelli M, Minisola S, Barale M, Barbaro D, Mansueto F, Battaglia S, Bonaccorsi G, Caliri S, Cavioni A, Colangelo L, Corbetta S, Coretti F, Dito G, Gavioli V, Ghigo E, Giannattasio R, Lapi P, Maiorana B, Marra C, Mazzantini M, Morini E, Nannipieri F, Nuzzo V, Parri F, Perna S, Santori R, Procopio M. Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study. Aging Clin Exp Res. 2024 Feb 12;36(1):38. doi: 10.1007/s40520-024-02696-9.
PubMed 38345765