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Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women (IOPForteo)

Primary Purpose

Menopause, Fracture, Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Teriparatide (PTH 1-34)

About this trial

This is an interventional treatment trial for Menopause focused on measuring Teriparatide, Forteo, Osteopenia, Osteoporosis, Fracture, Low Bone Density, Premenopausal women

Eligibility Criteria

20 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Premenopausal women of all races.
Ages 20 to 48.
Regular menses (at least 8 periods in the last 12 months).
FSH < 20 mIU/ml during the early follicular phase, to exclude women in the perimenopause.
Fracture subjects: documented low trauma fracture(s) at age >= 18 (e.g., fracture associated with a fall from a standing height or less).
Low BMD subjects: DXA BMD T score less than or equal to 2.5 at the LS, total hip, femoral neck or distal radius, who have not had a fracture.
Control subjects: DXA BMD T score greater than or equal to 1.0 at the LS, total hip, femoral neck and distal radius, who have not had a fracture.
All subjects must use appropriate birth control methods to prevent pregnancy for the duration of teriparatide treatment.

Exclusion Criteria:

Secondary Causes of Osteoporosis.
Disorders of mineral metabolism: primary or secondary hyperparathyroidism (serum intact PTH > 65 pg/ml), vitamin D deficiency (serum 25OHD < 30 ng/ml), hypercalciuria (>300 mg/g creatinine), Paget's disease, clinical osteomalacia, osteogenesis imperfecta (OI).
Recent pregnancy or lactation (within past year).
Prolonged amenorrhea (> 6 months) during reproductive years (except during pregnancy or lactation).
History of anorexia nervosa.
Malignancy, except cured basal or squamous cell skin carcinoma.
Endocrinopathy: hyperthyroidism (elevated serum thyroxine and/or suppressed TSH), untreated hypothyroidism, Cushing's syndrome, prolactin-secreting pituitary adenoma.
Renal insufficiency (serum creatinine above upper limit of female normal range).
Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity above upper normal limit).
Intestinal disorders (celiac disease, pancreatic insufficiency, inflammatory bowel disease).
History or current use of glucocorticoids, anticonvulsants, anticoagulants, diuretics, methotrexate.
Current use of depot preparations of progesterone or GnRH agonists.
Current use of drug therapies for osteoporosis (estrogen preparations other than contraceptives, raloxifene, bisphosphonates, calcitonin, PTH). Subjects who agree to discontinue use of these medications will be eligible to participate 6 months after discontinuing raloxifene or calcitonin, and 12 months after discontinuing bisphosphonates. Total exposure to bisphosphonates must be < 1 year. Subjects who have taken PTH at any time in the past will not be eligible.
Additional contraindications to teriparatide use: Unexplained elevated total or bone specific alkaline phosphatase or prior external beam or implant radiation therapy involving the skeleton.

Sites / Locations

Creighton University
Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women with Idiopathic osteoporosis (IOP)

Arm Description

Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months

Outcomes

Primary Outcome Measures

Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)

Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.

Secondary Outcome Measures

Full Information

NCT ID

NCT00697463

First Posted

June 11, 2008

Last Updated

July 24, 2018

Sponsor

Columbia University

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00697463

Brief Title

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Acronym

IOPForteo

Official Title

Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

August 20, 2008 (Actual)

Primary Completion Date

January 3, 2012 (Actual)

Study Completion Date

January 3, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide [PTH(1-34)], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.

Detailed Description

Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. In studies of IOP in men, histomorphometric indices of bone formation are depressed, and affected men respond to PTH(1-34) with robust increases in lumbar spine (LS) bone mineral density (BMD). This is the beginning of the third year of an R01 (AR4989603) investigating the etiology and pathogenesis, as well as the histomorphometric and bone microarchitectural features of IOP in premenopausal women. There is evidence of markedly decreased bone formation and microarchitectural deterioration with decreased mechanical competence/strength. Teriparatide [PTH(1-34)] is an anabolic agent that stimulates bone formation and improves bone microarchitecture. Based on findings, the investigators hypothesize that teriparatide will significantly increase BMD and improve microarchitecture in premenopausal women with IOP. This is an open-label study of carefully characterized premenopausal women with IOP who are participating in a NIH-funded study and who have fragility fractures or very low bone density. Participants in the study will receive 18-24 months of teriparatide and the effects on BMD and microstructure, bone mechanical competence, and bone turnover will be assessed. In order to assess whether teriparatide stimulates bone formation to the same extent in women with IOP as it does in normal women, the study will compare the short-term changes (2 and 4 weeks) in biochemical markers of bone formation in response to teriparatide between women with IOP and normal women who are participating in another NIH-funded study as controls.

6. Conditions and Keywords

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

Menopause, Fracture, Osteoporosis

Keywords

Teriparatide, Forteo, Osteopenia, Osteoporosis, Fracture, Low Bone Density, Premenopausal women

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Women with Idiopathic osteoporosis (IOP)

Arm Type

Experimental

Arm Description

Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months

Intervention Type

Drug

Intervention Name(s)

Teriparatide (PTH 1-34)

Other Intervention Name(s)

Forteo

Intervention Description

20 micrograms subcutaneous injection daily

Primary Outcome Measure Information:

Title

Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)

Description

Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.

Time Frame

Baseline, Month 18 or 24 reported

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Premenopausal women of all races. Ages 20 to 48. Regular menses (at least 8 periods in the last 12 months). FSH < 20 mIU/ml during the early follicular phase, to exclude women in the perimenopause. Fracture subjects: documented low trauma fracture(s) at age >= 18 (e.g., fracture associated with a fall from a standing height or less). Low BMD subjects: DXA BMD T score less than or equal to 2.5 at the LS, total hip, femoral neck or distal radius, who have not had a fracture. Control subjects: DXA BMD T score greater than or equal to 1.0 at the LS, total hip, femoral neck and distal radius, who have not had a fracture. All subjects must use appropriate birth control methods to prevent pregnancy for the duration of teriparatide treatment. Exclusion Criteria: Secondary Causes of Osteoporosis. Disorders of mineral metabolism: primary or secondary hyperparathyroidism (serum intact PTH > 65 pg/ml), vitamin D deficiency (serum 25OHD < 30 ng/ml), hypercalciuria (>300 mg/g creatinine), Paget's disease, clinical osteomalacia, osteogenesis imperfecta (OI). Recent pregnancy or lactation (within past year). Prolonged amenorrhea (> 6 months) during reproductive years (except during pregnancy or lactation). History of anorexia nervosa. Malignancy, except cured basal or squamous cell skin carcinoma. Endocrinopathy: hyperthyroidism (elevated serum thyroxine and/or suppressed TSH), untreated hypothyroidism, Cushing's syndrome, prolactin-secreting pituitary adenoma. Renal insufficiency (serum creatinine above upper limit of female normal range). Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity above upper normal limit). Intestinal disorders (celiac disease, pancreatic insufficiency, inflammatory bowel disease). History or current use of glucocorticoids, anticonvulsants, anticoagulants, diuretics, methotrexate. Current use of depot preparations of progesterone or GnRH agonists. Current use of drug therapies for osteoporosis (estrogen preparations other than contraceptives, raloxifene, bisphosphonates, calcitonin, PTH). Subjects who agree to discontinue use of these medications will be eligible to participate 6 months after discontinuing raloxifene or calcitonin, and 12 months after discontinuing bisphosphonates. Total exposure to bisphosphonates must be < 1 year. Subjects who have taken PTH at any time in the past will not be eligible. Additional contraindications to teriparatide use: Unexplained elevated total or bone specific alkaline phosphatase or prior external beam or implant radiation therapy involving the skeleton.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Shane, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adi Cohen, MD

Organizational Affiliation

Columbia University

Official's Role

Study Director

Facility Information:

Facility Name

Creighton University

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

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