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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00479037
First received: May 23, 2007
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Full Length Parathyroid Hormone, PTH(1-84)
Drug: Strontium Ranelate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 24-week, International, Multi Centre, Randomised, Open Label, Parallel Group, Phase IV Clinical Trial Investigating Changes in Bone Formation Markers in Postmenopausal Women With Primary Osteoporosis Treated With Either PTH(1-84) or Strontium Ranelate

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial [ Time Frame: Baseline and 24 weeks of treatment ] [ Designated as safety issue: No ]

    P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen.

    Bone marker measurements were done by blood analysis.


  • Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial [ Time Frame: Baseline and 24 weeks of treatment ] [ Designated as safety issue: No ]

    BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts.

    Bone marker measurements were done by blood analysis.



Secondary Outcome Measures:
  • Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial [ Time Frame: Baseline and 24 weeks of treatment ] [ Designated as safety issue: No ]

    CTX is a marker of bone resorption, which is a degradation product of bone collagen.

    Bone marker measurements were done by blood analysis.



Enrollment: 82
Study Start Date: April 2007
Study Completion Date: July 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTH(1-84) Drug: Full Length Parathyroid Hormone, PTH(1-84)
Once daily subcutaneous injection in the abdomen by self administration
Other Name: Preotact
Active Comparator: Strontium Ranelate 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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479037

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00479037     History of Changes
Other Study ID Numbers: FP-006-IM, 2006-006065-16
Study First Received: May 23, 2007
Results First Received: March 31, 2011
Last Updated: May 4, 2012
Health Authority: Austria: Ethikkommission
Spain: Spanish Agency of Medicines

Keywords provided by Nycomed:
postmenopausal women with primary osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hormones
Strontium ranelate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014