Back to results

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Primary Purpose

Osteoporosis, Postmenopausal

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

teriparatide

Placebo

Calcium Supplement

Vitamin D Supplement

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Ambulatory, postmenopausal women.
A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal & 3 times the upper limit of normal at baseline).

Exclusion Criteria:

Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.
Nephrolithiasis or urolithiasis in the 2 years prior to randomization.
Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level.
Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator.
Treatment with androgens or other anabolic steroids in the 6 months prior to randomization.
Treatment with calcitonins in the 2 months prior to randomization.
Treatment with estrogen
Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization.
Treatment with corticosteroids.
Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization.
Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization.
Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal.
Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization.
Treatment with calcium- or aluminum-containing antacids
Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization.
Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium & vitamin D run-in phase.

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.
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.
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 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

LY333334 40 micrograms/day plus calcium and vitamin D

LY333334 20 micrograms/day plus calcium and vitamin D

Placebo plus calcium and vitamin D

Outcomes

Primary Outcome Measures

To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.

Secondary Outcome Measures

To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis

To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites

To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.

To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.

To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis

To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.

To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)

To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.

To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.

To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.

To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.

Full Information

NCT ID

NCT00670501

First Posted

April 29, 2008

Last Updated

April 29, 2008

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00670501

Brief Title

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Official Title

Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

August 1996 (undefined)

Primary Completion Date

April 1999 (Actual)

Study Completion Date

April 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.

6. Conditions and Keywords

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

Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1637 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

LY333334 40 micrograms/day plus calcium and vitamin D

Arm Title

Arm Type

Experimental

Arm Description

LY333334 20 micrograms/day plus calcium and vitamin D

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo plus calcium and vitamin D

Intervention Type

Drug

Intervention Name(s)

teriparatide

Other Intervention Name(s)

LY333334, Forteo, Forsteo

Intervention Description

40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase

Intervention Type

Drug

Intervention Name(s)

teriparatide

Other Intervention Name(s)

LY333334, Forteo, Forsteo

Intervention Description

20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.

Intervention Type

Drug

Intervention Name(s)

Calcium Supplement

Intervention Description

Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement

Intervention Type

Drug

Intervention Name(s)

Vitamin D Supplement

Intervention Description

Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement

Primary Outcome Measure Information:

Title

Time Frame

Baseline, randomization, 24 , 36, and 60 months

Secondary Outcome Measure Information:

Title

Time Frame

Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.

Title

Time Frame

Randomization, 12, 24, 36, 48 and 60 months

Title

Time Frame

Baseline, randomization, 24 months, 60 months

Title

Time Frame

As clinically needed throughout the trial

Title

Time Frame

Randomization, 12, 24, 36, 48, and 60 months

Title

Time Frame

Randomization, 12 and 24 months

Title

Time Frame

Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months

Title

To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.

Time Frame

Months 1, 3, 6, 12, 18, 24, 30, 36 and 60

Title

To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.

Time Frame

Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months

Title

Time Frame

Randomization, 12, 24, 36, 48, and 60 months

Title

Time Frame

Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory, postmenopausal women. A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae. Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal & 3 times the upper limit of normal at baseline). Exclusion Criteria: Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease). Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis). Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism. Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization. Nephrolithiasis or urolithiasis in the 2 years prior to randomization. Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level. Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator. Treatment with androgens or other anabolic steroids in the 6 months prior to randomization. Treatment with calcitonins in the 2 months prior to randomization. Treatment with estrogen Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization. Treatment with corticosteroids. Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization. Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization. Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal. Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization. Treatment with calcium- or aluminum-containing antacids Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization. Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium & vitamin D run-in phase.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CT LILLY (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

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.

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

City

Capital Federal

Country

Argentina

Facility Name

City

Nedlands

Country

Australia

Facility Name

City

Graz

Country

Austria

Facility Name

City

Brussels

Country

Belgium

Facility Name

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

City

Praha

Country

Czech Republic

Facility Name

City

Aarhus

Country

Denmark

Facility Name

City

Kuopio

Country

Finland

Facility Name

City

Szeged

Country

Hungary

Facility Name

City

Tel-Hashomer

Country

Israel

Facility Name

City

Arenzano

Country

Italy

Facility Name

City

Amsterdam

Country

Netherlands

Facility Name

City

Christchurch

Country

New Zealand

Facility Name

City

Kristiansand

Country

Norway

Facility Name

City

Warszawa

Country

Poland

Facility Name

City

Uppsala

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

19250060

Citation

Prevrhal S, Krege JH, Chen P, Genant H, Black DM. Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin. 2009 Apr;25(4):921-8. doi: 10.1185/03007990902790993.

Results Reference

derived

Learn more about this trial

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

We'll reach out to this number within 24 hrs