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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AR073191-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide only | Active Comparator | daily subcutaneous injection teriparatide for 3 months |
|
| Denosumab only | Active Comparator | one dose of subcutaneous injection denosumab |
|
| Denosumab and teriparatide | Active Comparator | daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | teriparatide daily subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cancellous Bone Formation Rate at Month 3 | Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens. Bone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated. Mineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. Mineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them. | 3 months after first dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Leder, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
37 participants enrolled in the study. 3 participants withdrew their consent very soon after signing the consent form and PRIOR to randomization to a treatment arm. Thus we are reporting this as 37 enrolled in the study and 34 enrolled AND randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide Only | daily subcutaneous injection teriparatide for 3 months Teriparatide: teriparatide daily subcutaneous injection |
| FG001 | Denosumab Only | one dose of subcutaneous injection denosumab Denosumab: denosumab subcutaneous injection |
| FG002 | Denosumab and Teriparatide | daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab Teriparatide: teriparatide daily subcutaneous injection Denosumab: denosumab subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
refers to subjects enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide Only | daily subcutaneous injection teriparatide for 3 months Teriparatide: teriparatide daily subcutaneous injection |
| BG001 | Denosumab Only | one dose of subcutaneous injection denosumab Denosumab: denosumab subcutaneous injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cancellous Bone Formation Rate at Month 3 | Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens. Bone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated. Mineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. Mineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them. | refers to number of subjects who had bone biopsies available for analysis. | Posted | Mean | Standard Deviation | mm3/mm2/day | 3 months after first dose of study drug |
adverse event data was collected from baseline to approximately 1 month after study completion, for an average duration of 5 months per participant (assuming that the participant completed the whole study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriparatide Only | daily subcutaneous injection teriparatide for 3 months Teriparatide: teriparatide daily subcutaneous injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| phototoxic dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | phototoxic dermatitis likely secondary to demeclocycline used for biopsy labelling |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rhinorrhea | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Leder | Massachusetts General Hospital | 617-724-2039 | bzleder@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2021 | Jul 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Denosumab | Drug | denosumab subcutaneous injection |
|
|
| BG002 | Denosumab and Teriparatide | daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab Teriparatide: teriparatide daily subcutaneous injection Denosumab: denosumab subcutaneous injection |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Lumbar Spine bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) (g/cm2) | Mean | Standard Deviation | g/cm2 |
|
| Femoral Neck BMD by DXA (g/cm2) | Mean | Standard Deviation | g/cm2 |
|
| Total Hip BMD by DXA (g/cm2) | Mean | Standard Deviation | g/cm2 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Teriparatide Only | daily subcutaneous injection teriparatide for 3 months Teriparatide: teriparatide daily subcutaneous injection |
| OG001 | Denosumab Only | one dose of subcutaneous injection denosumab Denosumab: denosumab subcutaneous injection |
| OG002 | Denosumab and Teriparatide | daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab Teriparatide: teriparatide daily subcutaneous injection Denosumab: denosumab subcutaneous injection |
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 5 |
| 13 |
| EG001 | Denosumab Only | one dose of subcutaneous injection denosumab Denosumab: denosumab subcutaneous injection | 0 | 9 | 0 | 9 | 6 | 9 |
| EG002 | Denosumab and Teriparatide | daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab Teriparatide: teriparatide daily subcutaneous injection Denosumab: denosumab subcutaneous injection | 0 | 12 | 1 | 12 | 9 | 12 |
|
| transient syncopal event | Cardiac disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| propagation of fracture at biopsy site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |