A Dose-response Study With Strontium Malonate in Postmenopausal Women
A Dose-response Study With Strontium Malonate in Postmenopausal Women
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.
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.
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