Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia

NCT06464718 | Completed DMC

• 1 other identifier: 3390
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Osteopenia is characterized by bone mineral density (BMD) being lower than normal but not reaching the osteoporosis threshold, poses a serious problem for women after menopause. Osteopenia is a precursor to osteoporosis that is associated with increased risk of fractures, morbidity, and mortality. Using strategies to improve or maintain bone density is important for preventing osteoporosis and its associated complications. The combination of collagen peptide (CP) with calcium and vitamin D supplementation may provide several ways to improve bone health. This study aims to provide preliminary evidence of the effectiveness of traditional medicine in improving bone health through the effectiveness of CP.

Conditions

Osteopenia

Keywords

Bone mineral density; collagen peptide; osteoporosis; osteopenia; vitamin D3

Outcome Measures

Primary Outcomes (4)

• Blood Test

  Calcium levels in blood

  baseline and after 3 months

• Blood Test

  Vitamin B

  baseline and after 3 months

• Blood Test

  Osteocalcin

  baseline and after 3 months

• Dexa Scan

  Bone Mineral Density

  baseline and after 3 months

Study Arms (2)

Fortibone

EXPERIMENTAL

Drug: Fortibone

Chewable Tablet

ACTIVE COMPARATOR

Drug: Chewable Tablet

Interventions

Fortibone DRUG

Participants were given daily sachet containing 5g of Bio active collagen peptides (Fortibone). Electrolyte mix containing 500 mg calcium as calcium lactate, 4 MCg calcitriol and selenised yeast rich in vitamin D3 (400IU) (Colabone®, Vivapharm SA).

Fortibone

Chewable Tablet DRUG

calcium compound containing 25 g calcium carbonate (500mg elemental calcium) and vitamin D3 400IU taken daily

Chewable Tablet

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Postmenopausal
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal patients
• (-1. 0\>T-score\>-2. 5)

You may not qualify if:

• fracture,
• primary hyperparathyroidism

Sponsors & Collaborators

• Frontier Medical and Dental College, Abbotabad: lead

Study Sites (1)

Frontier Medical and Dental College

Abbottābād, KPK, Pakistan

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group A comprised of 15 subject who were given daily sachet containing 5g of Bio active collagen peptides (Fortibone). Electrolyte mix containing 500 mg calcium as calcium lactate, 4 MCg calcitriol and selenised yeast rich in vitamin D3 (400IU) (Colabone®, Vivapharm SA). Group B (control) consisted of 15 subjects who consumed a sweet formed from a chewable tablet with 1. A calcium compound containing 25 g calcium carbonate (500mg elemental calcium) and vitamin D3 400IU taken daily, these are potent supplements that are often used in practice, as per the researchers' recommendations

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: June 20, 2022
• Primary Completion: December 10, 2022
• Study Completion: January 16, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)