postmenopausal osteoporosis MedDRA version: 20.0 Level: HLGT Classification code 10013296 Term: Bone, calcium, magnesium and phosphorus metabolism disorders System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: DIDROGYL - 1.5 MG/10 ML GOCCE ORALI, SOLUZIONEFLACONE 10 ML
Product Name: didrogyl
Product Code: 024139014
Pharmaceutical Form: Oral solution
INN or Proposed INN: CALCIFEDIOLO
CAS Number:
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetic of 25(OH)D3 in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol. To evaluate the efficacy of two different dosages of calcifediol in the achievement of serum levels of 25(OH)D3 higher than 30 ng/ml in women with postmenopausal osteoporosis.;Secondary Objective: To evaluate the serum levels of 1-25(OH)2D3 and of PTH in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol. To evaluate the effects of two different dosages of calcifediol on muscular performances. To evaluate the effects of two different dosages of calcifediol on serum levels of myostatin.;Primary end point(s): a) to evaluate the pharmacokinetic of 25(OH)D3 in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol. b) to evaluate the efficacy of two different dosages of calcifediol in the achievement of serum levels of 25(OH)D3 higher than 30 ng/ml in women with postmenopausal osteoporosis.;Timepoint(s) of evaluation of this end point: a) 0, 15 g.g, 1 month, 2 months, 3 months and 6 months. b) 1 month, 2 months, 3 months and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) To evaluate the serum levels of 1-25(OH)2D3 and of PTH in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol. b) To evaluate the effects of two different dosages of calcifediol on muscular performances. c) To evaluate the effects of two different dosages of calcifediol on serum levels of myostatin.;Timepoint(s) of evaluation of this end point: a) 0, 15 g.g, 1 month, 2 months, 3 months e 6 months. b) 0, 1 month, 2 months, 3 months and 6months. c) 0, 1 months, 2 months, 3 months and 6 months. | — |
Countries
Italy
Contacts
Public ContactUOC Medicina Interna 1
Azienda Ospedaliera Senese
Outcome results
None listed