Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

NCT ID: NCT01753856

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

Brief Summary

The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teriparatide

20 micrograms (µg) teriparatide administered subcutaneously (SC) once every day for 6 months.

Demeclocycline (DEM): Beginning 18 days prior to randomization: Days 1, 2, 3 and 16, 17, 18: 150 milligrams (mg) DEM will be taken orally every 6 hours; Days 4 to15: DEM will not be administered.

Tetracycline (TET): Beginning 22 days prior to the biopsy procedure: Days 1, 2, 3 and 16, 17, 18: 250 mg TET will be taken orally every 6 hours; Days 4 through 15: TET will not be administered.

Calcium: Approximately 1000 milligrams per day (mg/day) administered orally.

Vitamin D: Approximately 800 to 1200 International Units per day (IU/day) administered orally.

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

Administered SC

Demeclocycline

Intervention Type: DRUG

Administered orally

Tetracycline

Intervention Type: DRUG

Administered orally

Calcium Supplement

Intervention Type: DRUG

Administered orally

Vitamin D

Intervention Type: DRUG

Administered orally

Denosumab

60 mg denosumab administered SC once in 6 months.

DEM: Beginning 18 days prior to randomization: Days 1, 2, 3 and 16, 17, 18: 150 mg DEM will be taken orally every 6 hours; Days 4 to 15: DEM will not be administered.

TET: Beginning 22 days prior to the biopsy procedure: Days 1, 2, 3 and 16, 17, 18: 250 mg TET will be taken orally every 6 hours; Days 4 through 15: TET will not be administered.

Calcium: Approximately 1000 mg/day administered orally.

Vitamin D: Approximately 800 to 1200 IU/day administered orally.

Group Type: ACTIVE_COMPARATOR

Denosumab

Intervention Type: DRUG

Administered SC

Demeclocycline

Intervention Type: DRUG

Administered orally

Tetracycline

Intervention Type: DRUG

Administered orally

Calcium Supplement

Intervention Type: DRUG

Administered orally

Vitamin D

Intervention Type: DRUG

Administered orally

Interventions

Teriparatide

Administered SC

Intervention Type: DRUG

Denosumab

Administered SC

Intervention Type: DRUG

Demeclocycline

Administered orally

Intervention Type: DRUG

Tetracycline

Administered orally

Intervention Type: DRUG

Calcium Supplement

Administered orally

Intervention Type: DRUG

Vitamin D

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY333334; Forteo; Forsteo

Eligibility Criteria

Inclusion Criteria

• Ambulatory, postmenopausal women (no vaginal bleeding for at least 2 years prior to screening) with osteoporosis
• Bone mineral density (BMD) T-score of at least -2.5 at femoral neck (FN), total hip (TH), or lumbar spine (LS) (Lumbar vertebrae L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic fracture after menopause, OR
• BMD T-score of at least -1.5 at FN, TH, or LS (L1-L4, with at least 2 evaluable vertebrae), and 1 or more atraumatic fractures after menopause (vertebral or nonvertebral). Nonvertebral fracture sites allowed are wrist, hip, pelvis, rib, humerus, clavicle, leg (femur, tibia, and fibula, excluding ankle)
• Laboratory values for serum calcium, parathyroid hormone (PTH), and alkaline phosphatase must be within the normal reference range

Exclusion Criteria

• Has an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of bone, a previous bone tumor, or radiation involving the skeleton
• Has an allergy or intolerance to teriparatide or denosumab and/or is a poor candidate for teriparatide or denosumab treatment (investigator should refer to local product prescribing information)
• Has a history of exposure to DEM or TET therapy in the 12 months prior to screening or a known allergy to DEM or TET
• Has a condition that could put the participant at additional risk of an adverse event (AE) due to the bone biopsy procedure (for example, bleeding disorder)
• Has undergone 2 previous iliac crest bone biopsies (1 in each iliac crest)
• Has a 25-hydroxyvitamin D concentration of <10 nanograms per milliliter (ng/mL)
• Has currently active or suspected (within 1 year prior to enrollment) diseases that affect bone metabolism, other than osteoporosis (such as renal osteodystrophy, hyperthyroidism, osteomalacia, or hyperparathyroidism)
• Has a history of certain cancers within 5 years prior to trial entry
• Current or recent (within 1 year prior to enrollment) celiac disease, inflammatory bowel disease, gastric bypass, or other malabsorption syndrome
• Has significantly impaired hepatic or renal function
• Has had treatment with systemic glucocorticoids in doses ≥5 mg/day prednisone/day or equivalent in the 6 calendar months prior to screening
• Has taken any intravenous osteoporosis medication
• Has had prior treatment with other bisphosphonates and not been off of them for a specific period of time before trial entry
• Has participated in any other clinical trial studying teriparatide, PTH, PTH analog, or denosumab, or prior or current treatment with teriparatide, PTH, PTH analog, or denosumab

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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, United States

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, United States

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, United States

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, United States

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, Canada

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, Canada

Countries

United States; Canada

References

Dempster DW, Zhou H, Recker RR, Brown JP, Recknor CP, Lewiecki EM, Miller PD, Rao SD, Kendler DL, Lindsay R, Krege JH, Alam J, Taylor KA, Melby TE, Ruff VA. Remodeling- and Modeling-Based Bone Formation With Teriparatide Versus Denosumab: A Longitudinal Analysis From Baseline to 3 Months in the AVA Study. J Bone Miner Res. 2018 Feb;33(2):298-306. doi: 10.1002/jbmr.3309. Epub 2017 Nov 15.

Reference Type: DERIVED

PMID: 29024120 (View on PubMed)

Other Identifiers

B3D-US-GHDV

Identifier Type: OTHER

Identifier Source: secondary_id

14592

Identifier Type: -

Identifier Source: org_study_id