Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Full Length Parathyroid Hormone, PTH(1-84); Strontium Ranelate
Intervention description: Once daily subcutaneous injection in the abdomen by self administration; The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water
Intervention MeSH terms: Strontium ranelate; Hormones; Parathyroid Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: postmenopausal women with primary osteoporosis

Summary:

      The primary objective of this trial is to show that PTH(1-84) is superior to strontium
      ranelate in bone formation measured as changes in bone formation markers over a treatment
      period of 24 weeks in postmenopausal women with primary osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be
        enrolled in the trial if the following inclusion/exclusion criteria apply.

        All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.

          1. Has the subject given informed consent according to local requirements before any
             trial related activities? (A trial related activity is any procedure that would not
             have been performed during the routine management of the subject).

          2. Is the subject female and at or above the age of 50?

          3. Has the subject been postmenopausal for more than 5 years - in the judgement of the
             investigator?

          4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5
             SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two
             assessable vertebrae, or at the total hip (right hip, if there is a right hip
             prosthesis, left hip can be used. If both hips are replaced the subject can be
             included with a lumbar scan only).

          5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such
             supplemental treatment and continue throughout the trial period, unless she develops
             hypercalcaemia?

          6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU)
             daily for at least 14 days (after screening) before blood sampling for eligibility
             evaluation? [*]

          7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper?

        [*] Note that inclusion criteria no. 6 can not be evaluated at the time for screening, must
        be evaluated at randomisation, visit 2. See also exclusion criteria and note [**].

        Exclusion criteria:

        All exclusion criteria must be answered "no" for a subject to be enrolled in the trial.

        Has the subject:

          1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within
             the last 1 month?

          2. ever been treated with any bisphosphonate in intravenous form (i.v.)?

          3. been treated with any bisphosphonates (alendronate, risedronate, or other
             bisphosphonates) for more than 3 years in total, or within the last 6 months?

          4. been treated with fluoride for more than 3 months within the last 10 years?

          5. ever been treated with strontium ranelate?

          6. ever been treated with teriparatide or PTH(1-84)?

          7. received or is the subject currently receiving chronic glucocorticosteroid treatment?

             Defined as more or equal to:

             5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg
             prednisolon or equivalent daily for 6 months during the last year. Local and
             inhalation steroids are permitted.

          8. been treated for cancer (other than basocellular skin cancer) within the last 5 years?

          9. ever received radiation therapy to the skeleton?

         10. ever had malignant disease affecting the skeleton? or does the subject:

         11. currently receive antiepileptic medication?

         12. take any other medication (other than calcium and vitamin D3) that is known to affect
             bone metabolism? - according to the investigator's opinion.

         13. have any known clinically significant diseases affecting calcium metabolism?

         14. have any known history of metabolic bone diseases other than primary osteoporosis
             including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or
             osteomalacia)?

         15. have any known history of hypersensitivity to parathyroid hormone or strontium or any
             of the excipients in the products?

         16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of
             calcium and vitamin D3 supplementation? [**]

         17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**]

         18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least
             14 days of calcium and vitamin D3 supplementation? [**]

         19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**]

         20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect
             measurement by serum creatinine)? [**]

         21. have severe impaired liver function ? [**]

         22. have phenylketonuria? or is the subject:

         23. at risk of having venous thromboembolism including pulmonary embolism? - according to
             the investigator's opinion.

         24. scheduled for vertebroplasty?

         25. currently participating in a clinical trial with an investigational medical product,
             or has done so within the last 90 days, or plan to do so within the next 32 weeks?
             Previous and current participation in non-interventional trials is allowed.

        [**] exclusion criteria no. 16 to 21 can not be evaluated before the result of the blood
        sampling (planned within the screening period and after at least 14 days of supplemental
        calcium/vitamin D3 intake) is available.