NCT02527668

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

To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia: a Double-blind Randomized Placebo-controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2015-08-19
• Last updated: 2019-04-30

Locations

1 site across 1 country: Switzerland