Clinical trial NCT00409032: A Dose-response Study With Strontium Malonate in Postmenopausal Women
Official title: A Dose-response Study With Strontium Malonate in Postmenopausal Women. A 12 Week, Multi National, Double Blind, Randomized, 5 Arms, Parallel Group Placebo Controlled Open Label Active Controlled, Phase II Study With 3 Dose Levels of Strontium Malonate and Protelos Within Post Menopausal Women With a BMDT-score Below -1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: osteoporosis
BMD
CTX
Post menopausal
strontium
bone turnover
clinical development
Lead sponsor: Osteologix
Sponsor class: INDUSTRY
First posted: 2006-12-08
Enrollment: 275
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.

Detailed description: 275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g Protelos® or placebo.

Patients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.

Apart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (at least 12 months since last menstruation).
* BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).
* 50 years of age.
* BMI\<30 kg/m2.
* Total S-Ca level within normal range.
* Ability to read and understand the information given.
* The patient has signed an informed consent form according to ICH E6 and local requirements before any study specific procedure is carried out.
* Ability to comply with study procedures.

Exclusion Criteria:

* History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).
* History of alcohol or drug abuse.
* Metabolic bone disease (e.g. pagets disease, bone cancer).
* History of VTE/DVT.
* History of kidney transplant.
* Bilateral oophorectomy.
* Relevant and treated reduced kidney or liver function.
* Any malignancy within the last 5 years (except basal cell carcinoma)
* Any chronic condition likely to affect absorption (e.g. Crohns disease, gluten enteropathy).
* Known genetic pre-disposition to VTE/DVT
* Known hypersensitivity to any of the active substances or excipients.
* 25-OH-vitamin D level below 25 nmol/L
* Any previous treatment with bisphosphonates, Strontium or fluoride.
* Treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, HRT, SERMs, PTH, phosphorus).
* Treatment during the last week with tetracycline, ciprofloxacin or loop diuretics.
* PTH out of normal range
* Use of any drug known to influence the coagulation process (aspirin and other NSAID allowed)
* Prothrombin time out of normal range (sec or INR)
* Inclusion in another clinical study within 30 days before randomization or during this study

Primary outcomes:
measure: CTX-1
Secondary outcomes:
measure: Other bio markers, BMD
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: PhaseOneTrials
city: Odense
country: Denmark
facility: Odense University Hospital
city: Northwood
country: United Kingdom
facility: Medinova Clinic
state: Middlesex
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Centre
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Centre
city: Reading
country: United Kingdom
facility: Synexus Limited Reading Clinical Research Centre
city: Sheffield
country: United Kingdom
facility: University of Sheffield
city: Waterloo
country: United Kingdom
facility: Synexus Crosby Clinical Research Centre
city: Wigan
country: United Kingdom
facility: Synexus Wigan Clinical Research Centre
Study officials:
affiliation: University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom
name: Richard Eastell, Professor, M.D.
role: PRINCIPAL_INVESTIGATOR
References: