Predictive Value of Bone Turnover Markers During Discontinuation With Alendronate

NCT03051620 | Completed Results DMC FDA Drug

• 1 other identifier: 2016-003110-27
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a cohort study comprising 136 patients with osteoporosis stopping treatment with alendronate. The study will contribute with new knowledge about biochemical markers of bone turnover as predictors of bone loss after stopping treatment with alendronate.

Conditions

Osteoporosis

Keywords

Bone turnover markers; Alendronate; Drug Holiday

Outcome Measures

Primary Outcomes (1)

• If Carboxy-terminal Collagen Crosslinks (CTX) Three and Six Months After Stopping Alendronate Predicted TH BMD (Total Hip BMD) Loss Above the Least Significant Change at Month 12 at the Individual Level.

  We constructed receiver operating characteristic (ROC) curves to evaluate if carboxy-terminal collagen crosslinks (CTX) three and six months after stopping alendronate predicted TH BMD loss above the least significant change (LSC) at month 12 at the individual level.

  Baseline and one year after baseline

Secondary Outcomes (4)

• Percent Change in Bone Turnover Markers Measured Three and Six Months After Stopping Alendronate Treatment and BMD After One and Two Years

  one and two years after baseline

• Number of Participants in Which CTX Increased Above the Least Significant Change

  From baseline to month 24

• The Number of Participants Who Lost BMD Beyond the Least Significant Change (LSC) at the Lumbar Spine and Total Hip.

  from baseline to month 24

• If Baseline Bone Turnover Markers at the Time of Alendronate Discontinuation Predict Changes in BMD After One and Two Years.

  Changes in TH BMD after one and two years.

Interventions

Discontinue alendronate DRUG

136 patients with osteoporosis stopping treatment with alendronate.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

140 patients with osteoporosis stopping treatment with alendronate.

You may qualify if:

• Postmenopausal women (postmenopausal for at least two years)
• Men above 50 years
• Treatment for at least five years with alendronate
• BMD T-score total hip \> -2.5
• BMD T-score lumbar spine (L1-L4) \> -4

You may not qualify if:

• Any low-energy fracture within the previous five years during alendronate treatment (not including fingers, toes, or skull)
• Low-energy vertebral fracture at any time
• Low-energy hip fracture at any time
• Ongoing treatment with glucocorticoids
• Metabolic bone disease
• Hormone replacement therapy
• Cancer
• Other conditions affecting bone metabolism

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (7)

• Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996 Dec 7;348(9041):1535-41. doi: 10.1016/s0140-6736(96)07088-2.

  PMID: 8950879 BACKGROUND

• Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, Rodriguez-Portales J, Downs RW Jr, Dequeker J, Favus M. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med. 1995 Nov 30;333(22):1437-43. doi: 10.1056/NEJM199511303332201.

  PMID: 7477143 BACKGROUND

• Shane E, Burr D, Ebeling PR, Abrahamsen B, Adler RA, Brown TD, Cheung AM, Cosman F, Curtis JR, Dell R, Dempster D, Einhorn TA, Genant HK, Geusens P, Klaushofer K, Koval K, Lane JM, McKiernan F, McKinney R, Ng A, Nieves J, O'Keefe R, Papapoulos S, Sen HT, van der Meulen MC, Weinstein RS, Whyte M; American Society for Bone and Mineral Research. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2010 Nov;25(11):2267-94. doi: 10.1002/jbmr.253.

  PMID: 20842676 BACKGROUND

• Khosla S, Burr D, Cauley J, Dempster DW, Ebeling PR, Felsenberg D, Gagel RF, Gilsanz V, Guise T, Koka S, McCauley LK, McGowan J, McKee MD, Mohla S, Pendrys DG, Raisz LG, Ruggiero SL, Shafer DM, Shum L, Silverman SL, Van Poznak CH, Watts N, Woo SB, Shane E; American Society for Bone and Mineral Research. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2007 Oct;22(10):1479-91. doi: 10.1359/jbmr.0707onj.

  PMID: 17663640 BACKGROUND

• Black DM, Schwartz AV, Ensrud KE, Cauley JA, Levis S, Quandt SA, Satterfield S, Wallace RB, Bauer DC, Palermo L, Wehren LE, Lombardi A, Santora AC, Cummings SR; FLEX Research Group. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA. 2006 Dec 27;296(24):2927-38. doi: 10.1001/jama.296.24.2927.

  PMID: 17190893 BACKGROUND

• Schwartz AV, Bauer DC, Cummings SR, Cauley JA, Ensrud KE, Palermo L, Wallace RB, Hochberg MC, Feldstein AC, Lombardi A, Black DM; FLEX Research Group. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. J Bone Miner Res. 2010 May;25(5):976-82. doi: 10.1002/jbmr.11.

  PMID: 20200926 BACKGROUND

• Solling AS, Harslof T, Bruun NH, Langdahl B. The predictive value of bone turnover markers during discontinuation of alendronate: the PROSA study. Osteoporos Int. 2021 Aug;32(8):1557-1566. doi: 10.1007/s00198-021-05835-4. Epub 2021 Jan 30.

  PMID: 33517477 DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anne Sophie Sølling
• Organization: Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark

annesoel@rm.dk

+45 78 45 54 75

Study Officials

• Bente L Langdahl, MD PhD DMSc

  Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: February 1, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-03

Locations

DK (1)