Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945788
Recruitment Status : Unknown
Verified September 2013 by Bio Sidus SA.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Bio Sidus SA

Tracking Information
First Submitted Date  ICMJE September 11, 2013
First Posted Date  ICMJE September 19, 2013
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
Change from baseline in Bone mineral Density at 6 months. [ Time Frame: Basal, Six months and One Year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Change from baseline in Bone mineral Density at 6 months. [ Time Frame: Basal and Six months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
Change from baseline in P1NP, Osteocalcin, C-terminal cross-linked telopeptide of type I collagen levels at 3 and 6 months [ Time Frame: Basal, 3, 6 and 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Change from baseline in P1NP, Osteocalcin, C-terminal cross-linked telopeptide of type I collagen levels at 3 and 6 months [ Time Frame: Basal, 3 and 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: January 21, 2014)
  • Change from baseline on bone mineral density asessed by High-resolution peripheral quantitative computed tomography (HR-pQCT) at 6 months [ Time Frame: Basal, six months and one year. ]
  • Number of patients with elevated serum calcium [ Time Frame: Basal, 1, 3, 6 and 12 months ]
Original Other Pre-specified Outcome Measures
 (submitted: September 16, 2013)
  • Change from baseline on bone mineral density asessed by High-resolution peripheral quantitative computed tomography (HR-pQCT) at 6 months [ Time Frame: Basal and six months ]
  • Number of patients with elevated serum calcium [ Time Frame: Basal, 1 - 3 and 6 months ]
 
Descriptive Information
Brief Title  ICMJE Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo
Official Title  ICMJE Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo
Brief Summary The primary objective of this study is to compare efficacy and safety of two formulations of teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with osteoporosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis With Pathological Fracture
Intervention  ICMJE Drug: Teriparatide (rDNA origin)
Study Arms  ICMJE
  • Active Comparator: Teriparatide Forteo
    20 micrograms/day plus calcium and vitamin D
    Intervention: Drug: Teriparatide (rDNA origin)
  • Experimental: Teriparatide Osteofortil
    20 micrograms/day plus calcium and vitamin D
    Intervention: Drug: Teriparatide (rDNA origin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 16, 2013)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

I. Female.

II. Age greater than or equal to 50 and less than 81 years.

III. Last menstrual period at least one year prior to signing the informed consent.

IV. Osteoporosis. Defined by the presence of:

BMD by DEXA with a T-score of -2.5 or lower on lumbar spine or T-score at the lumbar spine, femoral neck or total hip -2.0 or below, together with one or more vertebral fractures documented by lateral spine radiographs.

V. Have signed the informed consent

-

Exclusion Criteria:

I Bone alkaline phosphatase in the blood above the normal limit without any explanation.

II. Liver disease (AST or ALT> 2 x ULN). III. Renal disease (serum creatinine> 2.0 mg / dl) and / or creatinine clearance <30 ml / min IV. Hypercalcemia ([Ca]> 10.5 mg / dL). Patients with elevated PTH in the presence of albumin-corrected calcium within normal values can be re-evaluated.

V. Elevated blood PTH ([PTH]> 65 pg / ml) Patients with elevated PTH in the presence of albumin-corrected calcium within normal values can be re-evaluated.

VI. • Deficiency of vitamin D (25-OH vitamin D <16 ng / ml) or excess vitamin D (above 80 ng / ml blood). Patients who did not meet the inclusion criteria for vitamin D may receive a supplement (vitamin D) and be re-evaluated.

VII. • Anemia (hematocrit <32%).

VIII. • History of cancer (except basal cell carcinoma) or radiotherapy.

IX. Severe cardiopulmonary disease, including coronary heart disease: unstable angina, heart failure class III or IV or any other condition that the investigator believes may prevent participation safely and complete the protocol procedures.

X. Major psychiatric disease that in the opinion of the investigator, would prevent to give properinformed consent or complete the study procedures.

XI. Excessive alcohol or substance abuse that in the opinion of the investigator prevents giving informed consent or complete proper protocol procedures.

XII. Congenital or acquired bone disease, other than osteoporosis (including osteomalacia, hyperparathyroidism or Paget's disease)

XIII. Regarding the history of ingestion of oral bisphosphonates: After assessment of adequate adherence (compliance greater than 75%), if the patient received six months of treatment, she should have a bisphosphonate-free period of six months. If she took more than six months, the bisphosphonate-free period must be 12 months.

XIV. Current or within the last 3 months before study entry estrogen use, selective estrogen receptor modulators use or calcitonin use in therapeutic doses.

XV. Current use of systemic corticosteroids (oral or parenteral) for more than 14 days in the last 6 months. Vaginal estrogen and isoflavones are permitted .

XVI.Current or previous use of teriparatide, other PTH analogues as patches or injectables, strontium, fluorine or any intravenous bisphosphonate therapeutic dose, XVII. Known hypersensitivity to pharmaceuticals derived from bacterial cells. XVIII. Hypersensitivity to teriparatide or to any of its excipients. XIX.Nephrolithiasis or urolithiasis in activity, according to the investigator opinion in the 5 years prior to randomization.

XX.Inflammatory bowel disease, malabsorption syndrome or any sign of intestinal calcium malabsorption

XXI. Treatment with androgens or anabolic steroids in the 6 months prior to randomization.

XXII. Any medical condition that in the investigator opinion would contraindicate treatment with an investigational drug.

XXIII. Treatment with coumarin and indandione derivatives in the 3 months prior to randomization or treatment with heparins (at doses> 10,000 U / day) for more than 30 days in the 6 months prior to randomization.

XXIV.Treatment with any other drug known to affect bone metabolism, in therapeutic doses,in the 6 months prior to randomization.

XXV.Treatment with an investigational drug during the month prior to randomization. -

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01945788
Other Study ID Numbers  ICMJE 1301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bio Sidus SA
Study Sponsor  ICMJE Bio Sidus SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bio Sidus SA
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP