search
Back to results

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

Primary Purpose

Postmenopausal Osteoporosis With Pathological Fracture

Status
Unknown status
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Teriparatide (rDNA origin)
Sponsored by
Bio Sidus SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis With Pathological Fracture

Eligibility Criteria

50 Years - 81 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. -

Sites / Locations

  • Instituto de Investigaciones Metabolicas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Teriparatide Forteo

Teriparatide Osteofortil

Arm Description

20 micrograms/day plus calcium and vitamin D

20 micrograms/day plus calcium and vitamin D

Outcomes

Primary Outcome Measures

Change from baseline in Bone mineral Density at 6 months.

Secondary Outcome Measures

Change from baseline in P1NP, Osteocalcin, C-terminal cross-linked telopeptide of type I collagen levels at 3 and 6 months

Full Information

First Posted
September 11, 2013
Last Updated
January 21, 2014
Sponsor
Bio Sidus SA
search

1. Study Identification

Unique Protocol Identification Number
NCT01945788
Brief Title
Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo
Official Title
Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Sidus SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis With Pathological Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide Forteo
Arm Type
Active Comparator
Arm Description
20 micrograms/day plus calcium and vitamin D
Arm Title
Teriparatide Osteofortil
Arm Type
Experimental
Arm Description
20 micrograms/day plus calcium and vitamin D
Intervention Type
Drug
Intervention Name(s)
Teriparatide (rDNA origin)
Primary Outcome Measure Information:
Title
Change from baseline in Bone mineral Density at 6 months.
Time Frame
Basal, Six months and One Year
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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.
Title
Number of patients with elevated serum calcium
Time Frame
Basal, 1, 3, 6 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Facility Information:
Facility Name
Instituto de Investigaciones Metabolicas
City
Ciudad Autonoma de Buenos Aires
Country
Argentina

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs