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Register:	ISRCTN
Last refreshed on:	21 May 2018
Main ID:	ISRCTN82719233
Date of registration:	31/03/2006
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public title:	A double-blind, multicentric, multinational randomised study to assess the effects of one year administration of 2 g per day of strontium ranelate versus marketed bisphosphonates in women with postmenopausal osteoporosis on bone microarchitecture as measured by high-resolution peripheral-quantitative computed tomography (p-QCT)
Scientific title:	A double-blind, multicentric, multinational randomised study to assess the effects of one year administration of 2 g per day of strontium ranelate versus marketed bisphosphonates in women with postmenopausal osteoporosis on bone microarchitecture as measured by high-resolution peripheral-quantitative computed tomography (p-QCT)
Date of first enrolment:	31/10/2005
Target sample size:	72
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN82719233
Study type:	Interventional
Study design:	Double-blind randomised controlled study (Treatment)
Phase:	Not Specified

Countries of recruitment
Australia	France	Germany	Switzerland

Contacts

Name:	René Rizzoli
Address:	Hôpital Cantonal de Genève Département de Réhabilitation et Gériatrie Service des Maladies Osseuses 24, Rue Micheli?du-Crest 1211 Geneve 14 Switzerland
Telephone:
Email:
Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria: 1. Women of at least 50 years old
2. Postmenopausal for at least five years
3. Osteoporosis
Exclusion criteria: 1. Body mass index (BMI) <18 or >30 kg/m^2
2. Skeletal disease
3. Severe malabsorption
4. Significant and evolutive hyperthyroidism

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Post-menopausal osteoporosis
Musculoskeletal Diseases
Post-menopausal osteoporosis

Intervention(s)

Strontium ranelate (S12911) versus marketed bisphosphonates.

Primary Outcome(s)

Assessment of trabecular bone volume to tissue volume

Secondary Outcome(s)

Assessment of bone density, bone structure and bone markers

Secondary ID(s)

2006-002732-22

CL3-12911-019

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

First Ethics Committee approval obtained on 21/09/2005 in France, ref: 2005-064-2

Results

Results available:	Yes
Date Posted:
Date Completed:	28/02/2008
URL:

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