| Primary | Number of Participants With Normal/Abnormal Bone Histology | The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone. | All enrolled patients who had at least one evaluable biopsy | Posted | | Number | | Participants | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
| | | Title | Denominators | Categories |
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| Normal lamellar bone | | | | Normal mineralization | | | | Osteoid | | |
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| Secondary | Bone Histomorphometry: Cancellous Bone Volume | Cancellous (trabecular) bone volume (Tb.V) is the relative volume of total cancellous bone measured (TV), expressed as percentage, that is occupied by trabeculae. Cancellous bone volume was measured using Fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques. | All enrolled patients with at least one biopsy evaluable for histomorphometry | Posted | | Median | Inter-Quartile Range | percentage of total volume | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Trabecular Number | Trabecular number (Tb.N) is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Tb.N is a measure of trabecular connectivity and decreases with bone loss. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | mm^-1 | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Trabecular Separation | Trabecular separation (Tb.Sp) is the mean distance in mm between trabeculae (measured by integrated computer graphics). Tb.Sp increases with trabecular bone loss. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Trabecular Thickness | Mean trabecular thickness (Tb.Th) is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Tb.Th is reduced by aging and osteoporosis. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Cortical Width | Cortical width correlates with dual photon absorptiometric (DPX) measurements of bone density. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Surface Density | Surface density is calculated by total bone (trabecular) surfaces / total tissue volume. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | mm^2 /mm^3 | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Osteoblast - Osteoid Interface | Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percentage of osteoid surface | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Osteoid Surface | Osteoid surface is expressed as a percentage total bone surface. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percentage of bone surface | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Osteoid Width | Osteoid thickness (width; O.Th) is the mean thickness of osteoid seams on cancellous surfaces. O.Th is normally <12.5 µm. Increased O.Th suggests abnormal mineralization (osteomalacia). | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Wall Thickness | Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Eroded Surface/Bone Surface | Eroded surface is expressed as a percentage of total bone surface. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percentage of bone surface | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Osteoclast Number - Length Based | Osteoclast number expressed per mm of bone. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | 1/mm | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Osteoclast Number - Surface Based | Osteoclast number expressed per bone surface area. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | 1/100 mm | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Single-label Surface | Single-label surface is expressed as a percentage of total bone surface. The presence of a single label indicates that mineralization was occurring during only one labeling period. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percentage of bone surface | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Double-label Surface | Double-label surface is expressed as a percentage of total bone surface. The presence of double labels indicates that normal bone mineralization was actively occurring over the labeling interval. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percentage of bone surface | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Total Mineralizing Surface | Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percentage of bone surface | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Mineral Apposition Rate | The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm/day | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Adjusted Mineral Apposition Rate | The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface). | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm/day | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Bone Formation Rate - Surface Based | Bone formation rate - surface based (BFR/BS) is the calculated rate at which cancellous bone surface is being replaced annually. BFR/BS is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface /total bone surface). | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | μm^3 /μm^2 /year | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Bone Formation Rate - Volume Based | Bone formation rate - volume based (BFR/BV) is the calculated rate at which cancellous bone volume is being replaced annually. BFR/BV is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume). | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percent of bone volume per year | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Formation Period | The formation period is the duration of an interval when a place on the bone surface is actively forming bone. The formation period is calculated as the wall width (thickness of new bone made in one cycle) divided by the mineral apposition rate. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | days | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Activation Frequency | The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency (Ac.f). Activation frequency is calculated as the bone formation rate / wall width. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | /year | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Osteoid Volume | Osteoid volume is expressed as a percentage of total bone volume. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | percentage of total volume | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Bone Histomorphometry: Mineralization Lag Time | The mineralization lag time is the time interval between osteoid secretion and its subsequent mineralization, in days. | All enrolled patients with at least one biopsy evaluable for histomorphometry. | Posted | | Median | Inter-Quartile Range | days | | 25-34 days post-Day 1 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | C-Telopeptide (CTX-1) | C-Telopeptide is a biochemical marker for bone turnover. Blood samples were drawn for assessment of CTX-1 levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle. | All enrolled patients with at least one evaluable biopsy | Posted | | Median | Inter-Quartile Range | ng/mL | | Day 3 or Day 20 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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| Secondary | Procollagen Type 1 N-terminal Peptide (P1NP) | Procollagen Type 1 N-terminal Peptide is a biochemical marker of bone turnover. Blood samples were drawn for assessment of P1NP levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle. | All enrolled patients with at least one evaluable biopsy | Posted | | Median | Inter-Quartile Range | μg/L | | Day 3 or Day 20 | | | | ID | Title | Description |
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| OG000 | Previous Denosumab | Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy. |
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