A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2g per day of strontium ranelate versus alendronate 70mg per week in women with postmenopausal osteoporosis on bone microarchitecture measured by high resolution peripheral-Quantitative Computed Tomography (p-QCT).

• Register: EUCTR
• Last refreshed on: 25 February 2013
• Main ID: EUCTR2006-002732-22-DE
• Date of registration: 20/10/2006
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier
• Public title: A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2g per day of strontium ranelate versus alendronate 70mg per week in women with postmenopausal osteoporosis on bone microarchitecture measured by high resolution peripheral-Quantitative Computed Tomography (p-QCT).
• Scientific title: A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2g per day of strontium ranelate versus alendronate 70mg per week in women with postmenopausal osteoporosis on bone microarchitecture measured by high resolution peripheral-Quantitative Computed Tomography (p-QCT).
• Date of first enrolment: 08/09/2006
• Target sample size: 72
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002732-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other:

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
. Women of at least 50 years old
. Postmenopausal for at least 5 years
. Diagnosis of osteoporosis
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
. Use of forbidden previous and concomitant treatment interfering with bone metabolism
. Evolutive cancers during the past 5 years with a risk of bone metastases
. BMI <18 or >30 kg/m2
. Severe malabsorption
. Skeletal disease
. Significant and evolutive hyperthyroidism


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Treatment of postmenopausal Osteoporosis to reduce the risk of hip and vertebral fractures
MedDRA version: 8.1 Level: PT Classification code 10031290 Term: Osteoporotic fracture

Intervention(s)

Trade Name: PROTELOS
Product Name: S12911
Product Code: S12911
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Strontium ranelate
CAS Number: 135459-90-4
Current Sponsor code: S12911-2
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Granules for oral suspension
Route of administration of the placebo: Oral use

Trade Name: FOSAMAX
Pharmaceutical Form: Tablet
INN or Proposed INN: Alendronate
CAS Number: 66376-36-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Assess the effects of strontium ranelate in comparison with alendronate on the bone microarchitecture in patients with postmenopausal osteoporosis

Primary end point(s): . Parameter of bone density and bone structure in 3D evaluation
. Bone perimeter in 2D evaluation

Secondary Objective:

Secondary ID(s)

CL3-12911-019

ISRCTN82719233