Changes in Biochemical Markers of Bone Turnover (Serum CTX and PlNP) After Initiation of a "Drug Holiday" From Bisphosphonates

NCT02575157 | Unknown

• 1 other identifier: NBHADH1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Bisphosphonates (BP) are widely used in the prevention and treatment of osteoporosis in postmenopausal women and older men. Recently, there has been concern about the risk of adverse events after several years of using these agents. This has resulted in a publication from the Food and Drug Administration that suggested that, for many individuals, a holiday from bisphosphonates might be considered after 4-5 years of continuous use. In that publication there was little, if any, guidance on how clinicians should proceed after the holiday is initiated.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (3)

• Changes in bone turnover markers.

  2 years

• Changes in bone mineral density

  2 years

• Changes in trabecular bone score

  2 years

Study Arms (1)

Discontinuing usage

NO INTERVENTION

Patients will discontinue use of bisphosphonates. Bone markers and BMD will be monitored until a need for reinitiation of treatment within 2-years is identified or needed.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Discontinuing usage

Eligibility Criteria

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

You may qualify if:

• Postmenopausal women or males \>50 years who have taken oral bisphosphonates (risedronate or alendronate) for five years or more, and in whom it is considered reasonable to initiate a holiday from the medication, or those who have been on a holiday for up to 3 months will be eligible for screening visit.
• Subjects whose 25(0H) D level is above 30 ng/ml (subjects with 25(0H)D from 10-29 ng/ml may be included after supplementation and assessment of serum 25(0H)D) level is above 30 ng/ml.

You may not qualify if:

• Current steroid treatment at or greater than 5 mg/day prednisone or equivalent.
• The use of any other bone active medication other than risedronate or alendronate.
• The use of teriparatide within the past 4 years.
• A contra-indication to the discontinuation of bisphosphonate (e.g. fracture during treatment, extremely low t-score).
• Subjects with fasting serum sCTX less than 100 pg/ml or greater than 300 pg/mL while taking bisphosphonates.
• Failure to bring 25(0H)D serum level to 30 ng/ml or greater.
• Metabolic bone disease other than osteoporosis.
• Abnormal thyroid function (may be included when thyroid function is shown to be normal by TSH). Per local lab assessment.
• Evidence of failure to adhere to bisphosphonate use -

Sponsors & Collaborators

• National Bone Health Alliance: lead
• Roche Pharma AG: collaborator
• National Osteoporosis Foundation: collaborator

Study Sites (1)

Taylor C. Wallace

Washington D.C., District of Columbia, 20036, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Taylor C Wallace, PhD

CONTACT

2708391776; taylor.wallace@nbha.org

David Lee, BS

CONTACT

3019439260; david.lee@nbha.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2015
• First Posted: October 14, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2018
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)