Replication of the VERO Osteoporosis Trial in Healthcare Claims Data

NCT04879420 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-VERO
• Study Type: observational
• Target: 12,757
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• New vertebral fractures

  Claims-based algorithm based on diagnosis codes for vertebral fractures. Please refer to study protocol in Documents Section for full details

  Through study completion (earliest of 730 days or censoring)

Secondary Outcomes (1)

• Non-vertebral fractures

  Through study completion (earliest of 730 days or censoring)

Study Arms (2)

Teriparatide

Reference Group

Drug: Teriparatide

Risedronate

Exposure Group

Drug: Risedronate

Interventions

Teriparatide DRUG

Teriparatide dispensing claim is used as the reference group.

Teriparatide

Risedronate DRUG

Risedronate dispensing claim is used as the exposure group.

Risedronate

Eligibility Criteria

• Age: 45 Years - 120 Years
• Gender Eligibility Details: Postmenopausal women with osteoporosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve a new-user, multicenter, propensity score-matched, retrospective cohort study design comparing teriparatide and risedronate in post-menopausal women.

You may qualify if:

• Postmenopausal women \>= 45 years of age at the time of entry into the trial, whose last menstrual period occurred at least 2 years prior to entry into the trial and are sufficiently mobile to complete study visits
• Women \< 55 years of age in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum FSH level \> 40 IU/L and serum estradiol level \< 20 pg/mL or \< 73 pmol/L.
• A minimum of 2 moderate (SQ2) or 1 severe (SQ3) vertebral fragility fractures \[radiographic evidence of at least two moderate (ie, a reduction in vertebral body height of 26-40%) or one severe (more than 40% reduction) prevalent vertebral fragility fracture\]
• AP lumbar spine or total hip or femoral neck BMD ≥ 1.5 SD below the average BMD for young healthy, non-Hispanic, Caucasian women (T-score ≤ -1.5 SD)

You may not qualify if:

• \[...\] previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation
• History of unresolved skeletal diseases that affect bone metabolism, other than osteoporosis, including renal osteodystrophy, osteomalacia, hyperparathyroidism (uncorrected), hypoparathyroidism, and intestinal malabsorption \[Day 365, Day 0\]
• Abnormally elevated values of serum albumin-corrected calcium levels at baseline, defined as ≥ 10.6 mg/dL (or ≥ 2.65 mmol/L). In cases with borderline non-eligible values (≥ 10.6 and ≤ 10.7 mg/dL), a re-test would be allowed during the screening period \[Day 30, Day 0\]
• Abnormally low values of serum albumin- corrected calcium levels at baseline, defined as \< 8.0 mg/dL (or \< 2.0 mmol/L). In cases with borderline non-eligible values (\> 7.8 to \< 8.0 mg/dL), a re-test would be allowed during the screening period to allow normalization with vitamin D and calcium supplements before the randomization visit \[Day 30, Day 0\]
• History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized. Patients with multiple myeloma or metastases to bone are excluded \[Day 1,825, Day 0\]
• Active liver disease or clinical jaundice. Significantly impaired hepatic function, defined as aspartate aminotransferase (AST) \> 75 U/L or alanine aminotransferase (ALT) \> 75 U/L or gamma-glutamyl transpeptidase (GGT) \> 300 U/L \[Day 365, Day 0\]
• Significantly impaired renal function as defined by a calculated endogenous creatinine clearance (ClCr) \< 30 mL/min using the following Cockcroft-Gault formula for ClCr (Cockcroft and Gold 1976) \[Day 365, Day 0\]
• History of nephrolithiasis or urolithiasis within 1 year prior to Visit 2. \[Day 365, Day 0\]
• Patients who have been treated with kyphoplasty or vertebroplasty within the last 6 months before Visit 2. \[Day 180, Day 0\]
• Patients with history of osteonecrosis of the jaw or who are, according to the clinical judgment of the investigator, at high risk to develop osteonecrosis of the jaw, including poor oral hygiene, scheduled invasive dental procedures, high doses of bisphosphonates and/or chemotherapy to treat malignancy \[All Data, Day 0\]
• Patients with history of atypical subtrochanteric or diaphyseal femoral fractures, according to the diagnostic criteria of the American Society for Bone and Mineral Research Task Force (Shane et al. 2010). \[All Data, Day 0\]
• Active or recent history of significant upper gastrointestinal disorders, such as esophageal disorders which delay esophageal transit or emptying (e.g. stricture or achalasia). \[Day 365, Day 0\]
• Poor medical or psychiatric condition for participating in a clinical study, in the opinion of the investigator. \[Day 0, Day 0\]
• History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to Visit 2, in the opinion of the investigator. \[Day 365, Day 0\]
• "Previous treatment with the following bone active drugs is allowed but treatment must be discontinued at Visit 1 or at the time indicated below:

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide; Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 10, 2021
• Study Start: October 29, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: July 27, 2023

Record last verified: 2021-05

Locations

US (1)