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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. 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
Information provided by (Responsible Party):
Bio Sidus SA

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis With Pathological Fracture Drug: Teriparatide (rDNA origin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo
Study Start Date : June 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Change from baseline in Bone mineral Density at 6 months. [ Time Frame: Basal, Six months and One Year ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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. ]
  2. Number of patients with elevated serum calcium [ Time Frame: Basal, 1, 3, 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01945788

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Instituto de Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires, Argentina
Sponsors and Collaborators
Bio Sidus SA
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Responsible Party: Bio Sidus SA Identifier: NCT01945788    
Other Study ID Numbers: 1301
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: September 2013
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Fractures, Spontaneous
Osteoporotic Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Fractures, Bone
Wounds and Injuries
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents