NCT02416271

Brief Summary

The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2001

Typical duration for phase_4

Geographic Reach
4 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

April 9, 2015

Last Update Submit

April 9, 2015

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline to 18 Months in Lumbar Spine BMD

    Baseline, 18 Months

Secondary Outcomes (12)

  • Percent Change from Baseline in Lumbar Spine BMD

    Baseline, 3 Months, 6 Months, 12 Months

  • Percent Change from Baseline in Total Hip and Femoral Neck BMD

    Baseline, 12 Months, 18 Months

  • Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine

    Baseline, 6 Months, 18 Months

  • Percent Change from Baseline in Cortical BMD at the Femoral Neck

    Baseline, 6 Months, 18 Months

  • Percent Change from Baseline in Trabecular BMD at the Femoral Neck

    Baseline, 6 Months, 18 Months

  • +7 more secondary outcomes

Study Arms (2)

Teriparatide

EXPERIMENTAL

20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.

Drug: TeriparatideDietary Supplement: CalciumDietary Supplement: Vitamin DDrug: Placebo-Oral

Alendronate

ACTIVE COMPARATOR

10 milligrams/day alendronate orally plus SC injection placebo for 18 months.

Drug: AlendronateDietary Supplement: CalciumDietary Supplement: Vitamin DDrug: Placebo-SC

Interventions

TeriparatideDRUG

Administered SC

Also known as: LY333334, Forteo, Forsteo
Teriparatide
AlendronateDRUG

Administered orally

Alendronate
CalciumDIETARY_SUPPLEMENT

Administered orally

AlendronateTeriparatide
Vitamin DDIETARY_SUPPLEMENT

Administered orally

AlendronateTeriparatide
Placebo-OralDRUG

Administered orally

Teriparatide
Placebo-SCDRUG

Administered SC

Alendronate

Eligibility Criteria

Age45 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with osteoporosis.
  • Ambulatory, 5 years or more past menopause.
  • BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.
  • Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase.

You may not qualify if:

  • Prior treatment with PTH or a PTH analogue.
  • Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month.
  • History of diseases other than postmenopausal osteoporosis that affect bone metabolism.
  • History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton).
  • Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.
  • Nephrolithiasis or urolithiasis within 2 years, or impaired renal function.
  • Abnormal uncorrected thyroid function.
  • Liver disease or clinical jaundice.
  • Alcohol or other drug abuse.
  • Poor medical or psychiatric risk for treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

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.

Mobile, Alabama, 36693, United States

Location

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.

Tustin, California, 92780, United States

Location

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.

Lakewood, Colorado, 80227, United States

Location

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.

Honolulu, Hawaii, 96814, United States

Location

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.

Chicago, Illinois, 60611, United States

Location

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.

Springfield, Illinois, 62704, United States

Location

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.

Indianapolis, Indiana, 46260, United States

Location

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.

West Boylston, Massachusetts, 01583, United States

Location

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.

Arden Hills, Minnesota, 55126, United States

Location

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.

St Louis, Missouri, 63110, United States

Location

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.

Morristown, New Jersey, 07960, United States

Location

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.

Greenville, North Carolina, 27834, United States

Location

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.

Portland, Oregon, 97213, United States

Location

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.

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

Providence, Rhode Island, 02903, United States

Location

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.

Recife, 52051, Brazil

Location

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.

São Paulo, 040024, Brazil

Location

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.

Mexico City, 14000, Mexico

Location

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.

Mezzanine, 06100, Mexico

Location

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.

San Juan, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

TeriparatideAlendronateCalciumVitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 14, 2015

Study Start

April 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

ME(2)BR(2)US(15)PR(1)