Postmenopausal Osteoporosis With Pathological FracturePhase 4NCT01945788
Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo
A Phase 4 study testing Teriparatide (rDNA origin) in people with Postmenopausal Osteoporosis With Pathological Fracture, run by Bio Sidus SA at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 81 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis With Pathological Fracture
- What is being tested?
- Teriparatide (rDNA origin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2013to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female.
- Age greater than or equal to 50 and less than 81 years.
- Last menstrual period at least one year prior to signing the informed consent.
- 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.
- Have signed the informed consent
- -
Who cannot join
- I Bone alkaline phosphatase in the blood above the normal limit without any explanation.
- 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.
- 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.
- • 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.
- • Anemia (hematocrit <32%).
- • History of cancer (except basal cell carcinoma) or radiotherapy.
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- 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.
- Major psychiatric disease that in the opinion of the investigator, would prevent to give properinformed consent or complete the study procedures.
- Excessive alcohol or substance abuse that in the opinion of the investigator prevents giving informed consent or complete proper protocol procedures.
- Congenital or acquired bone disease, other than osteoporosis (including osteomalacia, hyperparathyroidism or Paget's disease)
- 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.
- Current or within the last 3 months before study entry estrogen use, selective estrogen receptor modulators use or calcitonin use in therapeutic doses.
- 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
- Treatment with androgens or anabolic steroids in the 6 months prior to randomization.
- 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. -
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto de Investigaciones Metabolicas
Buenos Aires, Buenos Aires F.D.
About this study
Official title: Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo
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.
- Being tested
- Teriparatide (rDNA origin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teriparatide (rDNA origin)Drug
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide Forteo | Active comparator | 20 micrograms/day plus calcium and vitamin D Receives: Drug: Teriparatide (rDNA origin) |
| Teriparatide Osteofortil | Experimental | 20 micrograms/day plus calcium and vitamin D Receives: Drug: Teriparatide (rDNA origin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Bone mineral Density at 6 months.
Measured: Basal, Six months and One Year
Secondary outcomes (1)
Change from baseline in P1NP, Osteocalcin, C-terminal cross-linked telopeptide of type I collagen levels at 3 and 6 months
Measured: Basal, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Osteoporosis With Pathological FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio Sidus SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945788
- Sponsor's protocol ID
- 1301
- Status last verified
- Sep 2013
- First submitted
- 11 Sep 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo
- ClinicalTrials.gov ID
- NCT01945788
- Acronym / sponsor ID
- 1301
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Bio Sidus SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriparatide Forteo | Active comparator | Drug: Teriparatide (rDNA origin)20 micrograms/day plus calcium and vitamin D |
| Teriparatide Osteofortil | Experimental | Drug: Teriparatide (rDNA origin)20 micrograms/day plus calcium and vitamin D |
Who may qualify
- Ages
- 50 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female.
- Age greater than or equal to 50 and less than 81 years.
- Last menstrual period at least one year prior to signing the informed consent.
- 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.
Key exclusion criteria (20 listed)
- I Bone alkaline phosphatase in the blood above the normal limit without any explanation.
- 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.
- 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.
- • 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.
- • Anemia (hematocrit <32%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teriparatide (rDNA origin) | Drug | Teriparatide Forteo, Teriparatide Osteofortil |
Primary outcome
Change from baseline in Bone mineral Density at 6 months.
Time frame: Basal, Six months and One Year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide (rDNA origin) in people with Postmenopausal Osteoporosis With Pathological Fracture, run by Bio Sidus SA at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Bone mineral Density at 6 months. (time frame: Basal, Six months and One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.