Clinical Trial of pharmacokinetics of calcifediol (25OHD3) in women with postmenopausal osteoporosis
- Conditions
- postmenopausal osteoporosisMedDRA version: 20.0Level: HLGTClassification code 10013296Term: Bone, calcium, magnesium and phosphorus metabolism disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-005303-91-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 50
Post-menopausal women (amenorrea for at least 5 years).
Age between 55 and 70 years
Lumbar or Femoral T-score (DXA) = - 2.5 DS
Serum levels of 25(OH)D3 between 10 and 20 ng/ml
Informed Consent signed
Willingness and capacity to adhere to study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
Femoral T-score (DXA) = -3.0 DS
History of fragility fractures
Osteomalacia or Paget disease of bone
Secondary Osteoporosis (primary or secondary hyperparathyroidism, Cushings disease,etc)
Treatment with oestrogen, drugs for osteoporosis or drugs known to interfere with bone metabolism (glucocorticoids, anticonvulsants, heparin, antiretrovirals etc)
Diabetes Mellitus Type 1 and 2
Neoplastic Diseases
BMI < 18 or >29.9 kg/m2
Treatment with calcifediol, calcitriol or colecalciferol in the previous 2 months
Mental and cognitive disorders
Inability or unwillingness to adhere to the study protocol
Refuse to sign the informed Consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method