Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women

Condition(s) targeted: Osteoporosis, Post-Menopausal

Intervention: Teriparatide (Drug); Zoledronic Acid (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).

Official title: Skeletal Histomorphometry in Patients on Teriparatide or Zoledronic Acid Therapy

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Mineralizing surface(MS/BS)in the cancellous compartment of iliac crest bone biopsies after 6 months

Secondary outcome:

Mineralizing surface(MS/BS) in the endocortical compartment of iliac crest bone biopsies after 6 months

Activation frequency (Ac.f)in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Bone formation rate (BFR) in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Mineral apposition rate (MAR) in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Adjusted apposition rate (Aj.AR)in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Extent of single or double tetracycline labels per bone surface (sLS/BS),(dLS/BS)in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Single or double tetracycline labels, both single plus double tetracycline labels, or no tetracycline labels in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Average length of tetracycline double labels in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Standard static histomorphometric parameters in the cancellous and endocortical compartments of iliac crest bone biopsies after 6 months

Change in serum procollagen type I N-terminal propeptide (PINP) from baseline through 12 months

Change in serum carboxyterminal cross-linking telopeptide of type I collagen (CTX)from baseline through 12 months

Change in serum osteocalcin (OC) from baseline through 12 months

Minimum age: 55 Years. Maximum age: 89 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least

2 years prior to trial entry)

- Free of severe or chronically disabling conditions other than osteoporosis that will

impair ability to complete the trial

- Bone mineral density (BMD) T-score of at least -2. 5 at the femoral neck, total hip,

or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic fracture or,

- Bone mineral density (BMD) T-score of at least -1. 5 at the femoral neck, or total

hip, or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), and either 1 or more atraumatic vertebral fracture(s) or an atraumatic nonvertebral fracture in the opinion of the investigator. Nonvertebral fracture sites allowed are wrist, hip, pelvis, ribs,humerus,clavicle, leg (femur, tibia, and fibula, excluding the ankle).

- Serum calcium, PTH, alkaline phosphatase must be within normal reference range

Exclusion Criteria:

- Have an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of

bone, a previous bone tumor, or radiation involving the skeleton

- Are allergic or cannot tolerate teriparatide or zoledronic acid or any of their

ingredients or components

- Are allergic to tetracycline

- Have a history of exposure to tetracycline therapy in the 3 months prior to trial

entry

- Have participated in a prior parathyroid hormone (PTH) clinical trial or received

prior treatment with teriparatide, PTH, or other related medications

- Have a vitamin D level below 10 ng/ml

- Have a condition that could possibly put one at risk for an adverse event due to the

bone biopsy procedure (e. g. bleeding disorder)

- Have undergone two previous iliac crest bone biopsies (one in each iliac crest)

- Have taken any intravenous (IV) osteoporosis medication

- Have taken other oral osteoporosis medications and have not been off of them for a

specific period of time before trial entry

- Have a history of certain cancers in the 5 years prior to trial entry

- Have active liver disease

- Have significantly impaired kidney function

- Currently have active or suspected diseases that affect the bones, other than

osteoporosis

- Have active or recent history of significant gastrointestinal (stomach or intestinal)

disorders

- Have been treated with certain glucocorticoids for more than 30 days in the past 1

year prior to trial entry

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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., Calgary, Alberta T2N 4Z6, Canada; Not yet recruiting
Eli Lilly

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., Vancouver, British Columbia V6H 3X8, Canada; Recruiting
Eli Lilly

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., Oakland, California 94609, United States; Recruiting
Eli Lilly

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; Recruiting
Eli Lilly

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., Decatur, Georgia 30033, United States; Recruiting
Eli Lilly

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., Gainesville, Georgia 30501, United States; Recruiting
Eli Lilly

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., Bethesda, Maryland 20817, United States; Recruiting
Eli Lilly

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., Detroit, Michigan 48202, United States; Not yet recruiting
Eli Lilly

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., Omaha, Nebraska 68131, United States; Recruiting
Eli Lilly

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., Albuquerque, New Mexico 87106, United States; Recruiting
Eli Lilly

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 Haverstraw, New York 10993, United States; Not yet recruiting
Eli Lilly

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., Sainte-Foy, Quebec G1V 3M7, Canada; Not yet recruiting
Eli Lilly

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., Dallas, Texas 75390, United States; Not yet recruiting
Eli Lilly

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., Madison, Wisconsin 53705, United States; Recruiting
Eli Lilly

Starting date: July 2009
Ending date: October 2011
Last updated: October 5, 2009