Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Puerto Rico

Study Type

Interventional

Intervention

Teriparatide

About this trial

This is an interventional treatment trial for Osteoporosis, Post-Menopausal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Presents with severe osteoporosis based on the disease diagnostic criteria and upon physician assessment
Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men over 50 years of age with low impact fractures (fragility).
Outpatients without concomitant diseases and with life expectancy of at least 3 years, according to the medical criteria.
Cannot be on medicines that can disturb bone metabolism.
Patients should be capable of self-injection, to learn the use of Pen device and are in agreement with its use.

Exclusion Criteria:

Directly affiliated with the conduct of this study, or are the immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
Previously completed or withdrawn from this study or any other study investigating Teriparatide.
Secondary osteoporosis or any disease that affects the bone metabolism, as renal osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and intestinal malabsorption.
Cancer history in the 5 years prior to visit 1, with exemption of basocellular carcinoma treated and cervix carcinoma definitively treated at least 1 year before to visit 1

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Teriparatide

Outcomes

Primary Outcome Measures

To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, is able to produce reliable changes in the bone marker in a severe osteoporotic population in Puerto Rico.

Secondary Outcome Measures

To test the hypothesis that this group of patients will have a high score in the survey used by IOF as an instrument to check risk factors.

Test the hypothesis that patients will have a high score in the survey used by IOF as an instrument to check risk factors.

Full Information

NCT ID

NCT00532545

First Posted

September 18, 2007

Last Updated

September 18, 2007

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00532545

Brief Title

Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis

Official Title

Bone Marker Changes In One Month Treatment With TERIPARATIDE (LY333334) Injections (rDNA Origin) in Men and Postmenopausal Women With Severe Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, are able to produce reliable changes in the bone marker in a severe osteoporotic population

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Post-Menopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Description

Teriparatide

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Other Intervention Name(s)

LY333334

Intervention Description

Teriparatide 20 micrograms/daily subcutaneously

Primary Outcome Measure Information:

Title

To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, is able to produce reliable changes in the bone marker in a severe osteoporotic population in Puerto Rico.

Secondary Outcome Measure Information:

Title

To test the hypothesis that this group of patients will have a high score in the survey used by IOF as an instrument to check risk factors.

Title

Test the hypothesis that patients will have a high score in the survey used by IOF as an instrument to check risk factors.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Presents with severe osteoporosis based on the disease diagnostic criteria and upon physician assessment Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men over 50 years of age with low impact fractures (fragility). Outpatients without concomitant diseases and with life expectancy of at least 3 years, according to the medical criteria. Cannot be on medicines that can disturb bone metabolism. Patients should be capable of self-injection, to learn the use of Pen device and are in agreement with its use. Exclusion Criteria: Directly affiliated with the conduct of this study, or are the immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry. Previously completed or withdrawn from this study or any other study investigating Teriparatide. Secondary osteoporosis or any disease that affects the bone metabolism, as renal osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and intestinal malabsorption. Cancer history in the 5 years prior to visit 1, with exemption of basocellular carcinoma treated and cervix carcinoma definitively treated at least 1 year before to visit 1

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name