A clinical observational study to assess the effectiveness of Strontium Ranelate on bone protection in osteoporotic patients pre-treated with bisphosphonates. - Strontium following bisphosphonate therapy

Phase 1

• Conditions: Postmenopausal Osteoporosis; MedDRA version: 8.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2005-003138-16-GB
• Lead Sponsor: R+ D department, Hull and East Yorkshire NHS Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-25
• Study Completion: 2009-07-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) - Age: 50-75

2) - T score: <-2.5 at either hip or spine or a T score <2.0 and one BMD independent risk factor for fracture (previous osteoporotic fracture, maternal osteoporotic fracture, previous steroid use, BMI <19, untreated premature menopause) (typical criteria for patients considered as requiring treatment to reduced their risk of fracture).

3)-Fit into group 1 or 2 below:
Group1: no previous bisphosphonates.
Group 2: > 1 year treatment with oral bisphosphonates and stopped treatment within the last 1 month due to lack of effect or side effects. Also if treated with pamidronate for > 1 year and last infusion within the last 3 month. (to allow clear distinction between the study groups)

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

Significant renal disease. (creatinine clearance < 30 ml/min)
Prior treatment with Strontium Ranelate.
Active malignancy
Osteomalacia
Primary hyperparathyroidism
Patient is unable to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Assessing whether previous treatment of osteoporosis with a bisphosphonates affects the subsequent response to treatment with Strontium Ranelate.<br><br> ;<br> Secondary Objective: Assessment of the relative merits of different established techniques for monitoring the response of osteoporotic patients to Strontium Ranelate.<br> ;<br> Primary end point(s): The change from baseline in bone mineral density at 1 year will be compared between the 2 groups.<br><br> At the end of the first year subjects will be offered the chance to enter into the second year of the study. Informed consent will be taken for the second year. The drug treatment will remain the same but there will be 2 extra vists at 18 and 24 months. The end point for this extention will be bone mineral density at year 2 compared between the 2 groups.<br><br>