The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The age-related increase in falls is strongly associated with a decline in muscle strength by the mechanism of sarcopenia. There has been great interest in developing approaches to counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle mass with vitamin D that have muscular effect. However, a limited number of studies demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted in order to determine the effect of alfacalcidol on the upper-body muscle strength in Indonesian elderly women in age group of 60 or more who had low handgrip strength.

Detailed Description
-----------------
A total 122 elderly women were enrolled to this study. It was determined subjects with handgrip strength less than 22 kg and measured using handheld dynamometer. There were 95 subjects fulfilled the eligible criteria. These subjects were randomized into two groups, one group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo. Each subject was given calcium 500 mg/day. After 12 weeks of intervention, 88 subjects had the second muscle strength measurement (7 dropped out).

Official Title
-----------------
Phase 3 Study of Vitamin D Analog (Alfacalcidol) on Muscle Strength in Elderly Indonesian Women Who Have Low Handgrip Strength

Conditions
-----------------
Muscle Weakness

Intervention / Treatment
-----------------
* Drug: alfacalcidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly women in age group of 60 or more Subjects with handgrip strength less than or equal to 22 kg Exclusion Criteria: Hypercalcemia (serum calcium > 10.5 mg / dL) Can not understand instructions well (MMSE scale < 16) Depression (Geriatric Depression Scale> 10) Fracture, deformity, and pain with a visual analog scale (VAS) ≥ 4 on fingers and joints of the upper limb when the examination will be conducted Heart failure fc. III-IV or uncontrolled according to the New York Heart Association (NYHA) Neurological conditions (epilepsy, acute stroke, Parkinson's) Malignant hypertension (systolic blood pressure ≥ 200 mmHg and or diastolic blood pressure ≥ 120 mmHg) Blood malignancies and solid tumors Decreased function of the liver (cirrhosis, ALT increase above 2 times the upper normal limit ) Refusing to follow the research / not willing controls

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: white rice flour capsule<br>One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo for 12 weeks | |
| Active Comparator: alfacalcidol<br>One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo | Drug: alfacalcidol<br>* One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo<br>* Other names: BoneOne, C27H4402;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of muscle strength in the group that received alfacalcidol compared to placebo | After 12 weeks of intervention, 88 subjects had the second muscle strength measurement | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alfacalcidol, Handgrip, Muscle strength, Sarcopenia, Falls