A Dose-response Study With Strontium Malonate in Postmenopausal Women

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osteologix

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