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

Status unconfirmed · Not applicable

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT02575157

Run by

National Bone Health Alliance

People needed

120

Starts

2015-06-01

Expected to finish

2018-06-01

Last updated by the study team

2015-10-14

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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 -

Where it is running

• Taylor C. Wallace — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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