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To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia

NCT02527668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-04-30

No results posted yet for this study

Summary

Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score below pharmacologic treatment indication have limited treatment options in the prevention of osteoporosis/treatment of osteopenia. Further, there is a concern about long-term side effects of bisphosphonate treatment among young postmenopausal women, and hormone replacement therapy has been controversial. In a pilot study 20 microgram Calcifediol Hy.D improved several muscle related function in this target population within 4 months of treatment, which can help to prevent falls and associated bone fractures. Thus the main aim of this study is to test whether Calcifediol Hy.D at a daily dose of 20 μg / day improves muscle function (lower extremity test battery) compared with (1) placebo and compared with (2) 3200 Vitamin D3 IU per day, at 3 and 6 month follow-up. As a secondary and exploratory objective of this study, the investigators will compare the beforementioned doses on muscle strength and the quality of the bones, beside muscle mass, body composition and systolic and diastolic blood pressure measurements.

Conditions

  • Osteopenia/Osteoporosis

Interventions

DIETARY_SUPPLEMENT

Calcifediol

One capsule orally of Calcifediol (20 µg) per day with a meal for a duration of 6 months

DIETARY_SUPPLEMENT

Vitamin D3

One capsule orally of Cholecalciferol (3200 IU) per day with a meal for a duration of 6 months

OTHER

Placebo

One capsule orally of a Placebo capsule per day with a meal for a duration of 6 months

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Tufts University

    collaborator OTHER

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Heike Bischoff-Ferrari, Prof, Dr.PH · Center on Aging and Mobility, Klinik für Geriatrie, UniversitätsSpital Zürich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527668 on ClinicalTrials.gov