Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Teriparatide (Drug); Denosumab (Drug); Demeclocyline (Drug); Tetracycline (Drug); Calcium Supplement (Drug); Vitamin D (Drug)
Phase: Phase 4
Status: Completed
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 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
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).
Clinical Details
Official title: Anabolism Versus Antiresorption: A Quadruple Labeling Histomorphometry Study to Compare the Mechanism of Action of Teriparatide and Denosumab in Postmenopausal Women With Osteoporosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from Baseline to 3 Months in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies
Secondary outcome: Change from Baseline to 3 Months in Mineralizing Surface/Bone Surface (MS/BS) in the Endocortical Compartment, Intracortical Compartment, and Periosteal Compartment of Iliac Crest Bone BiopsiesProportion of Bone with Remodeling-Based Formation and Modeling-Based Formation Proportion of Overfilled Remodeling Sites Change from Baseline to 3 Months in Label Length within each Basic Multicellular Unit (BMU) Change from Baseline to 3 Months in Mineral Apposition Rate (MAR) Change from Baseline to 3 Months in Bone Formation Rate (BFR) Percent of Single or Double Tetracycline Labels per Bone Surface (sLS/BS), (dLS/BS) Change from Baseline to 3 Months in Intact Parathyroid Hormone (PTH) Change from Baseline to 3 Months in Serum Procollagen Type I N-terminal Propeptide (P1NP) Change from Baseline to 3 Months in Serum Osteocalcin Change from Baseline to 3 Months in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) Activation Frequency (Ac.f ) Adjusted Apposition Rate (Aj.AR) Number of Samples with Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels Percentage of Osteoid Volume (OV)/Bone Volume (BV) Percentage of Osteoid Surface (OS)/Bone Surface (BS) Osteoid Thickness (O.Th) Wall Thickness (W.Th) Percentage of Eroded Surface/Bone Surface (ES/BS)
Eligibility
Minimum age: 55 Years.
Maximum age: 89 Years.
Gender(s): Female.
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) (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 demeclocycline (DEM) or tetracycline (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
due to the bone biopsy procedure (e. g. bleeding disorder)
- Has undergone 2 previous iliac crest bone biopsies (1 in each iliac crest)
- Has a 25-hydroxyvitamin D concentration of <10 nanogram 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 milligrams/day (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
Locations and Contacts
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 V5Z 4E1, 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., Lakewood, Colorado 80227, 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 30501, 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 48202, 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 68131, 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., Sainte-Foy, Quebec G1V 3M7, Canada
Additional Information
Starting date: January 2013
Last updated: June 30, 2014
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