NCT07763509

Brief 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. 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

OsteopeniaOsteoporosisBone Health in Perimenopausal WomenMenopause Related ConditionsFracture Healing

Keywords

Osteoporosisosteopeniabone healthmenopauseFractures

Outcome Measures

Primary Outcomes (1)

  • Continuous Adherence to Assigned Calcium Intervention

    Measuring adherence to calcium intake

    4 weeks

Secondary Outcomes (1)

  • Gastrointestinal Symptom Rating Scale (GSRS) Score

    4 weeks

Other Outcomes (1)

  • Treatment Satisfaction

    4 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Calcium Carbonate 500 MG

Interventions

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-Rich Food
Calcium Carbonate 500 MGDIETARY_SUPPLEMENT

A commercially available calcium carbonate supplement providing 500 mg calcium, taken once daily with food for four weeks.

Calcium Carbonate Supplement

Eligibility Criteria

Age40 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Science Center, Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (3)

  • 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.

    PMID: 16636212BACKGROUND

  • Badamgarav 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.

    PMID: 16901022BACKGROUND

  • Rondanelli 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.

    PMID: 38345765BACKGROUND

Related Links

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosisFractures, Bone

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Jeff Zhu

    Weill Medical College of Cornell University

    STUDY DIRECTOR

Central Study Contacts

Adrienne Bitar, PhD

CONTACT

4154255198arj67@cornell.edu

Jennifer Han, PharmD

CONTACT

925-389-8080jhan@seennutrition.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study because participants can distinguish between the two interventions based on their physical form (chew versus tablet). To minimize branding bias, the calcium-rich food will be provided in unbranded packaging with no company name or product branding displayed.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
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.

Locations

US(1)