Denosumab will be administered at 120 mg per dose every 4 weeks for six months, with loading doses on days 8 and 15 of month 1.

Bone Diseases

Pain

Denosumab

National Institutes of Health Clinical Center

Denosumab Treatment for Fibrous Dysplasia

An Open Label Pilot Study of Denosumab Treatment for Fibrous Dysplasia

Assessment of the effects of denosumab on: 1. Markers of bone turnover: Beta-crosslaps C-telopeptides (bone resorption marker) &amp; Procollagen-1-propeptide (bone formation marker)

Secondary endpoint #3 - Pain assessments utilizing the Brief Pain Inventory scores

Secondary Endpoint #2 - Surrogate markers of a direct therapeutic effect of denosumab on FD lesions:-Semi-quantitative changes in RANKL, Ki67 (marker of cell proliferation), p16 (marker od cell senescence), and/or apoptosis index-Sentinel lesion intensity assessment measured by change in PET/CT

Exploratory endpoint #3 - Effect measured by change in other outcome measures. Bone density assessed by DXA. Physical Medicine and Rehabilitation evaluation.

Exploratory endpoint #2 - Denosumab discontinuation effect on:Biochemical markers of bone metabolism: beta-crosslaps C-telopeptides, procollagen-1 propeptide, bone specific alkalinephosphatase, osteocalcin, NTX-telopeptides

Exploratory Endpoint: -Effect of denosumab initiation and discontinuation on Serum calcium, phosphorus and parathyroid hormone-Serum circulating RANKL and osteoprotegerin (OPG), and RANKL/OPG levels.

Secondary outcome #1- Bone histomorphometric indices: Mineralized perimeter, Bone formation rate, Cortical width, Cortical area, Osteoid width, Osteoid perimeter, Mineral apposition rate

fibrous dysplasia of bone/phosphatase

Denosumab Treatment for Fibrous Dysplasia

The Influence of Bisphosphonates in the Oral Cavity in Children

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