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Completed

NCT Number: NCT00535860

Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis

The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Osteocentrum FN, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusive Criteria:

  • Post-menopausal women aged between 55 to 85 years (inclusive)
  • Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD.
  • Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values.

Main Exclusive Criteria:

  • Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation
  • Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
  • Prior osteoporosis treatment with fluoride or strontium at any time; or any IV treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization.
  • Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan

Treatment and study plan

Teriparatide

Drug

Daily for 96 days

Other names: Forteo, Forsteo, LY333334

Primary outcomes

  1. Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)

    Time frame: Baseline, 96 days

Secondary outcomes

  1. Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)

    Time frame: Baseline, 96 days

  2. hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.

    Time frame: Baseline, 96 days

  3. Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection

    Time frame: Baseline, 96 days

  4. Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection

    Time frame: Baseline, 96 days

  5. hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.

    Time frame: Baseline, 96 Days

  6. Percentage of patients with serum total calcium above the upper limit of normal range

    Time frame: Over 96 days

  7. Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range

    Time frame: Over 96 days

  8. Number of participants with hPTH (1-34) specific antibody immune response

    Time frame: Baseline, 96 days

  9. Draize score for erythema and edema

    Time frame: Over 96 Days

  10. Visual Analog Scale (VAS) pain assessment

    Time frame: Over 96 days

Sponsors and collaborators

Lead sponsor

TransPharma Medical

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) in Comparison to Subcutaneous Injection of Forteo in Postmenopausal Women With Osteoporosis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2007
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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