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

This is an interventional prevention trial for Osteopenia/Osteoporosis Read More

Inclusion Criteria:

• Women age 50 to 70
• Post-menopausal (defined as: at least 1 year after the last menstrual period)
• community-dwelling and ambulatory without help
• with documented osteopenia (BMD by DEXA t-score: < -1.0 and > -2.5 at the spine or hip) in the 6 months prior to enrolment or with documented osteoporosis (BMD by DEXA t-score: ≤ -2.5 at the spine or hip) and a FRAX score (online calculation tool of absolute 10 year fracture risk) below the Swiss age-dependent indication threshold for pharmacologic treatment for the 10-year risk of major osteoporotic fractures - at the screening visit and including DEXA (in the 6 months prior to enrolment) as part of the calculation
• body mass index > 18.5 and < 30 kg/m2
• 25(OH)D level < 24 µg/l (< 60 nmol/l)
• understands German in reading and writing plus able to read, understand, and complete questionnaires and tests
• willingness to limit additional vitamin D3 intake to 800 IU per day
• willingness to limit calcium supplement intake to 500 mg/day
• willingness to stop active vitamin D metabolites
• participant understands the study procedures, alternative treatments available and risks involved with the study and voluntarily agrees to participate by giving a written informed consent
• participant meets the routine clinical laboratory safety screening tests performed at screening visit
• participant is able and willing to perform all study tests, attend all required office visits, and provide blood and urine samples
• participant is able to swallow the study medication

Exclusion Criteria:

• Consumption of more than 1'000 IU vitamin D on any day in the 4 weeks prior to enrollment.
• Elevated serum calcium > 2.60 mmol/l adjusted for albumin if albumin ≤ 35 or ≥ 45g/l
• estimated creatinine clearance < 30 ml/min (Cockcroft and Gault = 140 - age(yr)*weight(kg)/ serum Cr(mmol/l))×(1.04 for women)
• severe visual or hearing impairment
• malabsorption syndrome (celiac diseases, inflammatory bowel disease).
• Pathologic fracture (excl. fractures due to osteoporosis) in the last year
• Fracture due to osteoporosis in the last 10 years
• Chemo therapy / Radiation due to cancer in the last year
• Treatment which has an effect on calcium metabolism (e.g. PTH, calcitonin, chronic cortisone intake > 5mg/day for more than 4 weeks in the last 12 months (except for inhalation and sporadic infiltration))
• Current treatment with a bisphosphonate
• For participants of the ancillary study "Muscle Biopsy" only: Treatment which has an effect on blood coagulation (e.g. factor X inhibitor, thrombin inhibitor, NSAR, low-molecular heparin, inhibitor for platelet aggregation, vitamin K antagonist) and/or abnormal blood coagulation status .
• Unwilling or unable to take study medication
• Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
• History of or current diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary hyperparathyroidism
• Individual that heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
• Individual is unlikely to adhere to the study procedures, to keep appointments, or is planning to relocate during the study.
• Individuals who are planning a stay in a "sunny" location (e.g. winter sun resort) for more than one month during the course of the study
• Medication which has an effect on 25-hydroxyvitamin D level (e.g. certain anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin))
• M. Paget (Ostitis deformans)
• Inflammatory arthritis (e.g. rheumatoid arthritis, Reiter syndrome, psoriasis arthritis)
• Participation in a study in the last 6 months, except for studies without drug-application, or any influence of the study-medication can be excluded