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

Not Applicable

Completed

• Conditions: Osteopenia
• Interventions: Drug: Chewable Tablet; Drug: Fortibone

• Registration Number: NCT06464718
• Lead Sponsor: Frontier Medical and Dental College, Abbotabad

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.

Detailed Description

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.The study was single blinded randomized controlled trial, involving 30 post-menopausal women that were equally divided into two groups by computer generated simple random sampling technique. Group A received bioactive collagen peptide along with calcium lactate, and vitamin D3. The control group (Group B) consisted of 15 participants who were given a chewable tablet daily, containing 1.25 grams of calcium carbonate (equivalent to 500 mg of elemental calcium) and 400 IU of vitamin D3.

Study Timeline

• Study Start: 2022-06-20
• Primary Completion: 2022-12-10
• Study Completion: 2023-01-16
• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-18
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• fracture,
• primary hyperparathyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewable Tablet	Chewable Tablet	-
Fortibone	Fortibone	-

Primary Outcome Measures

Name	Time	Method
Blood Test	baseline and after 3 months	Osteocalcin
Dexa Scan	baseline and after 3 months	Bone Mineral Density

Trial Locations

Locations (1)

Frontier Medical and Dental College; 🇵🇰 Abbottābād, KPK, Pakistan