--- title: Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis nct_id: NCT00051558 overall_status: COMPLETED phase: PHASE3 sponsor: Eli Lilly and Company study_type: INTERVENTIONAL primary_condition: Osteoporosis countries: United States, Austria, Belgium, Denmark, Norway, Puerto Rico canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00051558.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00051558" ct_last_update_post_date: 2009-03-12 last_seen_at: "2026-05-12T06:44:15.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis **Official Title:** Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis **NCT ID:** [NCT00051558](https://clinicaltrials.gov/study/NCT00051558) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 428 - **Lead Sponsor:** Eli Lilly and Company - **Conditions:** Osteoporosis - **Start Date:** 2002-11 - **Completion Date:** 2008-01 - **CT.gov Last Update:** 2009-03-12 ## Brief Summary Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis. ## Eligibility - **Minimum age:** 21 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Men or women age 21 years or older * Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening Exclusion Criteria: * Taking bisphosphonates within past 6 months * More than 30 micrograms/day of estradiol or equivalent in past 3 months * History of alcoholism or drug abuse in past year * Pregnant women or nursing mothers ``` ## Arms - **A** (EXPERIMENTAL) — Teriparatide 20 micrograms/day injection plus oral placebo, 36 months - **B** (ACTIVE_COMPARATOR) — Alendronate 10 mg/day oral plus injection placebo, 36 months ## Interventions - **Teriparatide** (DRUG) — 20 micrograms/day, injection, 36 months - **Alendronate Sodium** (DRUG) — 10 mg/day, oral, 36 months - **Placebo** (DRUG) — Oral placebo, daily, 36 months - **Placebo** (DRUG) — Injection placebo, daily, 36 months ## Primary Outcomes - **Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)** _(time frame: 18 month endpoint)_ — change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) ## Secondary Outcomes - **Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset** _(time frame: 18 month endpoint)_ - **Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined** _(time frame: 3, 6, 12, 18, 24, 36 months)_ - **Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset** _(time frame: 3, 6, 12, and 18 months)_ - **Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined** _(time frame: 24 and 36 months and Endpoint at 36 months)_ - **Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined** _(time frame: 18, 24, 36 months, and 18 and 36 month endpoints)_ - **Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined** _(time frame: 18, 24, 36 months, and 18 and 36 month endpoints)_ - **Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined** _(time frame: 12, 18, 24, and 36 months)_ - **Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined** _(time frame: 12, 18, 24, and 36 months)_ - **Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen** _(time frame: 1, 6, 18, and 36 months)_ - **Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen** _(time frame: 1, 6, 18, and 36 months)_ - **Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase** _(time frame: 1, 6, 18, and 36 months)_ - **Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments** _(time frame: 1, 6, 18, and 36 months)_ - **Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin** _(time frame: 1, 6, 18, and 36 months)_ - **Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures** _(time frame: 36 months)_ ## Locations (15) - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Loma Linda, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Palo Alto, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Aurora, Colorado, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Fargo, North Dakota, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Jamestown, North Dakota, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Milwaukee, Wisconsin, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Graz, Austria - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Vienna, Austria - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Brussels, Belgium - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Ghent, Belgium - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Leuven, Belgium - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Aarhus, Denmark - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Oslo, Norway - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Carolina, Puerto Rico - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Ponce, Puerto Rico ## Recent Field Changes (last 30 days) - `sponsor.lead` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|loma linda|california|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|palo alto|california|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|fargo|north dakota|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|jamestown|north dakota|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|milwaukee|wisconsin|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|graz||austria` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|vienna||austria` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|brussels||belgium` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|ghent||belgium` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|leuven||belgium` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|aarhus||denmark` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|oslo||norway` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|carolina||puerto rico` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) monday-friday from 9:00 am to 5:00 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician|ponce||puerto rico` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00051558.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00051558* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*