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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bio Sidus SA
ClinicalTrials.gov Identifier:
NCT01945788
First received: September 11, 2013
Last updated: January 21, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Postmenopausal Osteoporosis With Pathological Fracture
Drug: Teriparatide (rDNA origin)
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: Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo

Resource links provided by NLM:


Further study details as provided by Bio Sidus SA:

Primary Outcome Measures:
  • Change from baseline in Bone mineral Density at 6 months. [ Time Frame: Basal, Six months and One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Number of patients with elevated serum calcium [ Time Frame: Basal, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: June 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Teriparatide Forteo
20 micrograms/day plus calcium and vitamin D
Drug: Teriparatide (rDNA origin)
Experimental: Teriparatide Osteofortil
20 micrograms/day plus calcium and vitamin D
Drug: Teriparatide (rDNA origin)

  Eligibility

Ages Eligible for Study:   50 Years to 81 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. -

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01945788

Locations
Argentina
Instituto de Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires, Argentina
Sponsors and Collaborators
Bio Sidus SA
  More Information

No publications provided

Responsible Party: Bio Sidus SA
ClinicalTrials.gov Identifier: NCT01945788     History of Changes
Other Study ID Numbers: 1301
Study First Received: September 11, 2013
Last Updated: January 21, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee

Additional relevant MeSH terms:
Fractures, Spontaneous
Osteoporosis
Osteoporosis, Postmenopausal
Osteoporotic Fractures
Bone Diseases
Bone Diseases, Metabolic
Fractures, Bone
Musculoskeletal Diseases
Wounds and Injuries
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014