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

Lilly

Status and phase

Completed

Phase 4

Conditions

Osteoporosis, Post-menopausal

Treatments

Drug: Zoledronic Acid

Drug: Teriparatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00927186

B3D-US-GHDL (Other Identifier)

13032

Details and patient eligibility

About

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). After completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.

Enrollment

69 patients

Sex

Female

Ages

55 to 89 years old

Volunteers

No Healthy Volunteers

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, parathyroid hormone (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 PTH clinical trial or received prior treatment with teriparatide, PTH, or other related medications
Have a vitamin D level below 10 nanogram/milliliter (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