Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTH(1-84)

Group Type ACTIVE_COMPARATOR

Full Length Parathyroid Hormone, PTH(1-84)

Intervention Type DRUG

Once daily subcutaneous injection in the abdomen by self administration

Strontium Ranelate

Group Type ACTIVE_COMPARATOR

Strontium Ranelate

Intervention Type DRUG

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

Interventions

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Full Length Parathyroid Hormone, PTH(1-84)

Once daily subcutaneous injection in the abdomen by self administration

Intervention Type DRUG

Strontium Ranelate

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 Type DRUG

Other Intervention Names

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Preotact

Eligibility Criteria

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Inclusion Criteria

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?

Exclusion Criteria

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.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No